Effects of intradialytic exercise on physical performance

Transcription

1 University of New Mexico UNM Digital Repository Doctor of Physical Therapy Capstones Health Sciences Center Student Scholarship Effects of intradialytic exercise on physical performance Christi-Anne Hisaw University of New Mexico Follow this and additional works at: Recommended Citation Hisaw, Christi-Anne. "Effects of intradialytic exercise on physical performance." (2014). This Capstone is brought to you for free and open access by the Health Sciences Center Student Scholarship at UNM Digital Repository. It has been accepted for inclusion in Doctor of Physical Therapy Capstones by an authorized administrator of UNM Digital Repository. For more information, please contact

2 Effects of Intradialytic Exercise on Physical Performance By: Christi-Anne Hisaw Doctoral Candidate University of New Mexico School of Medicine Division of Physical Therapy Class of 2014 Advisor: Fred Carey, P.T., Ph.D Printed Name of Advisor: Signature: Date: Approved by the Division of Physical Therapy, School of Medicine, University of New Mexico in partial fulfillment of the requirements for the degree of Doctor of Physical Therapy. 1

3 Abstract Background/Purpose: According to the American Kidney Foundation, diabetes mellitus is the leading cause of kidney failure. In the acute care setting, patients requiring physical therapy are frequently unable to participate in physical therapy sessions secondary to the amount of time necessary to receive hemodialysis. Patients with kidney disease or failure already have a low level of physical performance. This makes it imperative that they receive the physical therapy needed to maintain the level of physical function required for their daily lives. The purpose of this paper is to evaluate the effects of exercise during hemodialysis on physical function compared to baseline measures. Case Description: The patient was a 63 year old female with diabetes mellitus--admitted for shortness of breath and a hypertensive emergency. She demonstrated inability to be safe enough to return to prior living situation with a new onset of significant generalized weakness. In addition, patient was unable to afford physical therapy after discharge from hospital secondary to lack of funding making it imperative to return patient to highest level of physical function as possible prior to discharge. Outcomes: Patient did not participate in intradialytic exercise. Although patient did not meet goals set for her by the evaluating physical therapist, patient was able to regain enough physical function to return to prior living situation. Despite this, patient would have benefitted from increased physical function to allow complete return to prior level of function. Discussion: If the patient was more medically stable, she could have possibly benefitted from participating in intradialytic exercise to allow for a complete return to prior level of function. Intradialytic exercise could potentially help many patients with similar conditions to allow for an overall increase in physical performance. This would allow for participation in exercise without the patient being required to make additional time for exercise and could potentially increase compliance with maintaining an exercise program. Section 1: Background and Purpose: The patient was a 63 year old female with a complicated past medical history, including diabetes mellitus Type II, and required hemodialysis 3 times per week to help regulate waste products. She presented to University of New Mexico hospital with generalized swelling, shortness of breath, and a significant decline in functional status 2

4 beginning two weeks prior to admission. This decrease in physical function was confirmed when the patient was evaluated by the physical therapy department five days after admission. It was determined that the patient required skilled physical therapy 3-5 days per week to assist with return to prior level of function. However, secondary to need for hemodialysis, patient was frequently out of hospital room and unable to receive physical therapy many days of the week. In addition, patient did not have funding and was unable to afford physical therapy after discharge from hospital. The only physical rehabilitation she would receive would be during her hospital admission and the patient would be discharged as soon as medically stable. With these factors in mind, the following PICO question was formed: In patients with Diabetes Mellitus requiring hemodialysis, do intradialytic exercises increase physical function compared to baseline? In 2009, 380,760 patients in the United States required hemodialysis according to the American Kidney Fund. 1 Those required to be on hemodialysis have some level of kidney disease, although the severity varies. Not all people who develop kidney disease have diabetes mellitus; however, diabetes mellitus is the leading cause of kidney disease. 1 No matter the cause, those with chronic kidney disease have lower physical and functional capacity when compared to the general population. In addition, hemodialysis patients are less active, have low exercise tolerance, and high physical deconditioning probably related to muscle atrophy, anemia, uremic myopathy and neuropathy, autonomic dysfunction, decreased flexibility, decreased muscle strength, malnutrition, and comorbidities. 2 Although exercise is encouraged in this population to help decrease these limitations and increase quality of life this population tends to be even less active than healthy, sedentary individuals. 3 In addition, hemodialysis is typically prescribed 3 times per week, 3 to 6 hours per session, and remains ongoing for the lifetime of the patient or until successful kidney transplantation. 4 With hemodialysis requiring so much time each week, people in this population are even less inclined to spend time exercising. However, if intradialytic exercise is a safe and effective intervention, the likelihood of this population staying more active might increase because it wouldn t require additional time outside of hemodialysis. This could potentially increase physical function and quality of life in this general population. Section 2: Case Description: Introduction: 3

5 The patient was transferred to University of New Mexico hospital from an out-of-town hospital secondary to hypertensive emergency, decreased urine output, severe anasarca, and fatigue. Evaluation by physicians revealed anasarca was likely due to combined heart failure and acute renal failure. Physicians first worked to control her blood pressure. Five days after admission, when no longer hypertensive, a referral for physical therapy was requested for overall deconditioning. Upon evaluation, it was discovered the patient had a significant decrease in physical function compared to prior level of function. Patient then received physical therapy treatments to assist with return to prior level while physicians continued to address her severe edema, decreased urine output, and fatigue. Examination: The patient was a 63 year old female admitted to the hospital on 11/9/13. She lived with her elderly sister and other dependent family member approximately 80 miles from the hospital. The patient lived in a mobile home with 6 stairs required to be negotiated in order to gain entry to the home. Patient was an uninsured, non-working individual and required minimal assistance from her sister with her activities of daily living prior to admission. Per patient, her past medical history consisted of: chronic back pain, hypertension, type II diabetes mellitus, and bilateral cataracts (can only see shadows). However, surgical history was not reported. Upon the physical therapy evaluation, patient required increased assistance compared to patient-reported prior level of function see details in Tests and Measures. Patient was cognitively intact and fully oriented. During a general systems review, patient endorsed a recent weight gain, progressive fatigue, orthopnea, and chest congestion when lying flat. However, she denied fever, chills, or a cough. Her medications included Metformin, Glipizide, and an unspecified anti-hypertensive medication. Sister of the patient reported she was physically unable to assist more than she previously was and they are unable to afford physical therapy or hired help after hospital discharge. Patient reported she wished to return home while only requiring the same amount of assistance she needed prior to admission (less than 25% of assistance with daily activities and ambulating independently). Tests and Measures: Right and Left Upper Extremity Strength and Range of Motion: o Active range of motion within functional limits and manual muscle testing grossly 4/5 bilaterally. Right and Left Lower Extremity Strength and Range of Motion: 4

6 o Active range of motion and strength appeared to be within functional limits; however, unable to fully assess secondary to edema. Neurological Assessment: o Muscle tone, sensation, coordination, and proprioception within normal limits. Bed mobility o Assistance from supine position to sitting position: Required moderate (50-74%) assistance from physical therapist Transfers o Assistance from sitting to a standing position: Required moderate (50-74%) assistance from physical therapist Ambulation o Required use of front wheeled walker, physical therapist keeping contact with patient by use of gait belt, and verbal and tactile cues for stability and maintaining balance. o Distance: 15 feet with decreased clearance and step length. Evaluation: Diagnosis: Impaired Muscle Performance (Pattern 4C), Impaired Joint Mobility, Motor Function, Muscle Performance, and Range of Motion Associated with Connective Tissue Dysfunction (Pattern 4D), Primary Prevention/Risk Reduction for Cardiovascular/Pulmonary Disorders (Pattern 6A),and Impaired Aerobic Capacity/Endurance Associated With Deconditioning (Patter 6B). Narrative Assessment: Patient was a 63 year old female admitted for generalized swelling and fatigue likely secondary to compensated heart failure and acute kidney failure. The patient presented with impaired functional mobility and decreased endurance compared to prior level of function. She required a significantly increased amount of assistance compared to prior to admission to hospital. In order for the patient to return home safely, the patient needed to demonstrate the ability to safely ambulate household distances (about 100 feet), negotiate 6 stairs in order to enter home, and require minimal amount of assistance (less than 25%) for her activities of daily living. Clinical Judgments and Problem List: 5

7 Problem List: Strength/Range of motion deficits Impaired functional mobility Bed mobility deficits Transfer deficits Ambulation deficits Balance deficits Decreased Activity Tolerance Decreased endurance Prognosis, Including Goals and Plan of Care: Goals: Prognosis and rehabilitation potential: Good Pt will perform bed mobility from a flat bed, with supervision, in 1 week to assist with return to independence with daily activities. Pt will perform transfer from bed to chair and chair to bed with modified independence using least restrictive device in 1 week to assist with return independence with daily activities. In 4 weeks, patient will ambulate 75 feet with modified independence, using least restrictive device, to assist with increased endurance for household ambulation distances. Patient will negotiate 6 stairs with modified independence, using least restrictive device, to assist with ability to enter residence. Plan of Care: Ambulate patient 3-5 times per week to assist with return to prior level of function until goals are met or patient discharged from hospital. Interventions: Bed mobility training, transfer training, gait training, therapeutic exercises, therapeutic activities, balance training, safety education. 6

8 Outcomes: Patient was discharged after medically stable. Patient did not have funding and was unable to transfer to a skilled nursing facility. Patient was progressing towards goals; however, did not meet the set goals before discharge from the hospital. Although patient continued to demonstrate deficits, the patient was able to return home with assistance. Patient was educated on importance of increasing her amount of activity out of bed and performing her activities of daily living as independently as possible in order to continue to improve function and maximize her independence. Section 3: Evidence Based Analysis Methodologies of Search: PICO question: In patients with Diabetes Mellitus that require hemodialysis, do intradialytic exercises increase physical function compared to baseline? Databases used: PubMed, CINAHL, and Cochrane Search key words/terms: Intradialytic exercise hemodialysis exercise exercise during dialysis physical function, exercise, dialysis Articles excluded: See attached chart for a detailed list. Number and list of articles included: Bullani R, El-Housseini Y, Giordano F, et al. Effect of Intradialytic Resistance Band Exercise on Physical Function in Patients on Maintenance Hemodialysis: A Pilot Study. Journal of Renal Nutrition. 2011; 21(1): Parsons T L, Toffelmire E B, King-VanVlack C E. Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006;87: Silva SF, Pereira AA, Silva WA, Simôes R, Barros Neto Jde R. Physical therapy during hemodialyse in patients with chronic kidney disease. J Bras Nefrol Jul- Sep;35(3):

9 Chen JLT, Godfrey S, Ng TT, et al. Effect of intra-dialytic, low-intensity strength training on functional capacity in adult haemodialysis patients: a randomized pilot trial. Nephrol Dial Transplant. 2010;25: Ragnarsdottir M, Malmberg E, Strandberg E, Indridason OS. Increased physical fitness among patients following endurance training during haemodialysis. Scandinavian Journal of Urology and Nephrology. 2012(46) Oh-Park M, Fast A, Gopal S, Lynn R, Frei G, Drenth R, Zohman L. Exercise for the dialyzed: Aerobic and strength training during hemodialysis. Am J Phys Med Rehabil. 2002;81: Reboredo Mde M, Henrique DM, Faria Rde S, Chaoubah A, Bastos MG, de Paula RB. Exercise training during dialysis reduces blood pressure and increases physical functioning and quality of life. Artif Organs Jul;34(7): Ribeiro R, Coutinho GL, Luras A, Barbosa AM, Camargo de Souza JA, Diniz DP, Schor N. Effect of resistance exercise intradialytic in renal patients chronic in hemodialysis. J Bras Nefrol. 2013;35(1):13-9. *See attached chart for more details about studies. Discussion: Many of the studies found that physical function could improve with the use of intradialytic exercise. The design for each of the studies was quite different from one another in regards to both the outcome measures, as well as the type of exercise prescribed. This made comparisons between studies difficult; however many of the studies utilized the 6-Minute Walk Test to help gauge improvement in physical function or performance to allow for some ease in comparison. Many of the studies seemed to suggest that improvement in physical function could be possible through intradialytic exercise. Although many other outcome measures showed mixed results, some studies suggested there could be improvement in other outcome measures, such as efficacy of dialysis, blood pressure, and quality of life. The results found are encouraging; however, need to be taken with caution secondary to the quality of the studies performed. Larger sample sizes and control groups needed to be implemented in the studies reviewed to aid in decreasing the amount of possible bias that could be introduced into the studies. Many of the studies found 8

10 excluded those with diabetes mellitus (the leading cause of kidney disease), as well as many other more complicated conditions. This is a cause for hesitation in regards to implementing this as an intervention for the selected patient as she had a complex medical history. In reviewing the literature, it was decided that this intervention was not appropriate for the patient; however, it could potentially be implemented for someone with a less complicated medical history. This could potentially become a program like cardiac or pulmonary rehabilitation programs that already exist. This would require additional research to be done to investigate exactly who is medically appropriate for this intervention, how often this should be performed, and the best type of exercise to have patients perform. These findings should be kept in mind; however reserve this treatment option until more research has been done. Conclusion: After a thorough search for the available research, there was not enough support to use this intervention on the selected patient secondary to her medical stability and complex medical history. In addition, even for less complicated patients receiving hemodialysis to manage their diabetes mellitus, there is not enough quality evidence to implement intradialytic exercise as an intervention. Although diabetes mellitus is the leading cause of kidney disease and failure, many studies state diabetes mellitus as an exclusion criterion for their study. Considering the prevalence of this condition, this is an area for future research. Most of the studies reviewed showed statistically significant improvement in not only physical function, but also in other factors such as quality of life and efficacy of dialysis. The studies were not of the highest quality. However, all of the positive results indicate this intervention could potentially have a huge impact on the lives of those receiving hemodialysis and more research needs to be done to decipher if this intervention is truly effective and safe for those receiving hemodialysis. 9

11 Summary of Effect of Intradialytic Resistance Band Exercise on Physical Function in Patients on Maintenance Hemodialysis: A Pilot Study Level of Evidence: 3B Purpose: According to this study, aerobic exercises during dialysis have not had great results in improving physical function. However, resistance exercises have shown better results even though they have not been studied as much. Resistance exercise equipment can be bulky and expensive. This study aimed to assess a cheap way to implement a resistance exercise program during dialysis by using resistance bands to help improve physical function. Methods: 11 patients performed lower extremity resistance exercises during dialysis 2 times per week for approximately 30 minutes for months. The patients physical function was assessed by 4 outcome measures: Tinetti Gait and Balance Instrument, Timed Up and Go test, One-Leg Balance test, and Six-Minute Walk Distance test. The patients were pre-tested before beginning the treatment sessions and were post-tested immediately after finishing the treatment sessions. Results: The Tinetti Gait and Balance Instrument and the Timed Up and Go tests showed statistically significant improvement from the pre-test of the patients. The One-Leg Balance test and the Six-Minute Walk Distance Test showed improvement; however, the change was not statistically significant. Critique: The results of this study are encouraging; however, due to the small sample size and lack of control group should be taken with caution. In addition, the patients medical histories were not discussed in the demographics. So, these results may not apply to more complex patients. This does encourage future, higher-quality studies to assess effectiveness of this intervention. Reference: Bullani R, El-Housseini Y, Giordano F, et al. Effect of Intradialytic Resistance Band Exercise on Physical Function in Patients on Maintenance Hemodialysis: A Pilot Study. Journal of Renal Nutrition. 2011; 21(1):

12 Summary of: Exercise Training During Hemodialysis Improves Dialysis Efficacy and Physical Performance Level of evidence: 3B Purpose: The purpose of this study was to, for 20 weeks, examine the effects of a low-intensity, aerobic, intradialytic exercise program on dialysis efficacy, physical function, and self-reported quality of life in patients requiring hemodialysis. Methods: Thirteen patients performed two 30-minute bouts of self-paced aerobic exercise on a weighted cycle ergometer or a mini-stepper during the first 2 hours of dialysis. They performed this intradialytic exercise 3 times per week for 20 weeks. Dialysis efficacy (via serum urea clearance), physical function (via 6-minute walk test), and quality of life (via Kidney disease quality of life short form) were measured at different points throughout the 20 weeks in order to track significant differences from baseline. Results: This study showed statistically significant differences in serum urea clearance indicating increased dialysis efficacy. The serum urea clearance levels increased by 11% in the first month and remained elevated throughout the 20 weeks at 18-19%. In addition, there were statistically significant differences in physical function as shown by the 6-minute walk test and was improved by 14%. Self-reported quality of life questionnaires showed no difference on quality of life. Critique: Although the study produced some statistically significant results in regards to physical function, and dialysis efficacy, these results may not apply to all hemodialysis patients. The study set the parameters of two 30-minute bouts of exercise to optimize the amount of serum urea clearance. Not all patients will have the endurance to participate in activity for that length of time especially those in the acute care setting. Due to the small sample size, the study may have had difficulty showing a statistically significant change in the quality of life of these patients; however, that cannot be assumed. The study would be of better quality if performed with a larger sample size, in addition to having a control group in order to more definitively prove these improvements in dialysis efficacy and physical function. 11

13 Reference: Parsons T L, Toffelmire E B, King-VanVlack C E. Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006;87:

14 Summary for: Physical Therapy During Hemodialyse in Patients with Chronic Kidney Disease Level of Evidence: 3B Purpose: The purpose of this study was to evaluate the effects of a combined aerobic and resistance intradialytic exercise program on physical function, muscle strength, quality of life, and vital signs after exertion for 16 months. Methods: 56 patients underwent a 16 month supervised exercise program consisting of both aerobic and resistance exercises. This exercise program was performed during dialysis 3 times per week for 20 minutes during the first 2 hours of dialysis. Patients were pre and post tested using the following outcome measures: 6-minute walk test for physical function--followed by the Borg scale and vital signs for perceived exertion and cardiovascular adaptations, respectively. In addition, 1RM maximum for knee extensors was tested for muscular strength and the SF-36 for quality of life. Results: Quality of life questionnaire only showed statistically significant improvement in the areas of functional capacity and pain for the SF-36. The heart rate and respiratory rates (at the end of the 6-minute walk test) before and after the program test were statistically significant indicating these rates could improve with training. Blood pressure did not change significantly, but it did remain constant when comparing before and after training. The Borg Scale scores for perceived exertion and the distance walked in the 6-minute walk tests were also shown to be statistically significant indicating patients were less tired after walking a longer distance. Critique: Having such a large population available for the study is rare. This study would have proven to be of better quality if the investigators had taken advantage of such a large participant size and split the subjects into a control and an experimental group. This would have made it easier to blind the participants and the investigators thus decreasing the amount of bias that potentially could be introduced into the study and, instead, increase the validity. However, the results do look encouraging when comparing the pre- and post- tests of the subjects in many areas: physical function, reduction of heart rate and respiratory rate, perceived exertion during activities, quality of life, and quadriceps strength. 13

15 Reference: Silva SF, Pereira AA, Silva WA, Simôes R, Barros Neto Jde R. Physical therapy during hemodialyse in patients with chronic kidney disease. J Bras Nefrol Jul-Sep;35(3):

16 Summary for: Effect of Intra-dialytic, low-intensity strength training on functional capacity in adult haemodialysis patients: a randomized pilot trial Level of Evidence: 2B Purpose: To examine the effects of an intradialytic, low-intensity, strength training exercise program for patients undergoing hemodialysis. Methods: 50 patients were randomly assigned to either an intradialytic low-intensity strength training program or an attention control group who received only exercises. The groups performed their given tasks two times per week during the first 2 hours of hemodialysis for a total of 48 sessions. The primary outcome was the SPPB (Short Physical Performance Battery Score) to assess physical function and was assessed either at 36 weeks or 24 weeks and carried forward. Secondary outcomes included lower body strength and body composition measured by knee extensor strength using the Nicholas Manual Muscle Tester and dual x-ray absorptiometry, respectively. In addition, quality of life was measured by the Physical Activity Scale for the Elderly, SF-36, and Activities of Daily Living questionnaire. Results: The primary outcome could only be computed in 44 of the original 50 patients. However, SPPB scores improved significantly in the strength training group compared to the attention control group 21.1% (43.1%) vs 0.2% (38.4%), respectively, p= These results suggest an increase in physical function. In addition, the strength training group also showed statistical significant improvements in knee extensor strength, leisure-time physical activity, and self-reported physical function and activities of daily living disability P=< 0.02.The study reports that adverse events were common; however deny relation to the study participation. Critique: This study had a better design than some of the others reviewed as indicated by the large number or participants & the random allocation to a group. However, there was a high drop-out rate, although the rate was the same in both groups. The amount of time the study originally wanted to observe the effect of the results for had to be shortened secondary to the drop-out rate, although they did analyze the results based on the mid-testing scores they collected. The study aimed at examining an older population and the effects of low-intensity exercise which seems 15

17 like a more feasible treatment option considering this population tends to have a more complex medical history. More studies of this nature need to be performed. Reference: Chen JLT, Godfrey S, Ng TT, et al. Effect of intra-dialytic, low-intensity strength training on functional capacity in adult haemodialysis patients: a randomized pilot trial. Nephrol Dial Transplant. 2010;25:

18 Summary for: Increased physical fitness among patients following endurance training during haemodialysis. Level of Evidence: 3B Purpose: The purpose of this study was to examine the effects of a moderate intensity endurance training exercise program during dialysis for 6 months on physical performance and the risk of falling in hemodialysis patients. Methods: Twenty-one patients underwent the following tests for baseline measures: 6-minute walk test, timed up and go, timed stand test, and Romberg s test. These tests were repeated at the 3 & 6 month marks. During the first half of each dialysis treatments, each patient would bicycle while confined to a bed. Vital signs were recorded and the Borg scale was utilized to monitor each patient. Intensity of the workout was aimed for on the Borg scale and ranged from minutes in duration according to the individual s capacity. Results: Nine of the 21 subjects were unable to complete even 3 months of training. Of the remaining 12 patients, 3 were not able to complete the entire 6 months of training. However, all patients who had completed at least 3 months of training had their results analyzed. At baseline, 8 patients had either a positive Romberg s test or a TUG >14 seconds to complete compared to only 3 patients at the 3 month mark. Significant improvement was shown in all measures of physical fitness (6-Min Walk Test, Timed Up and Go, and Timed Stand Test) with all p values= <0.05. Those 9 patients that completed the entire 6 months of training showed significant improvements in all physical fitness measures compared to baseline. In addition, there was significant improvement in the timed stand test between the 3 and 6 month measurements. Of the 6 patients at baseline that had either a positive Romberg s or TUG >14 seconds, only 1 patient, after 6 months of training had a TUG >14 seconds. Critique: There was a high drop-out rate in this study that already had a small patient sample; however, they did analyze all of the information they were able to collect. Since this study did not have a control group, it was impossible to blind either the participants or the investigators. This could possibly introduce a high amount of bias into the study. So, although the results have shown to be statistically significant in improving physical function, they should be taken with caution. More high quality studies would need to be performed before this type of intervention should be implemented into our practice. 17

19 Reference: Ragnarsdottir M, Malmberg E, Strandberg E, Indridason OS. Increased physical fitness among patients following endurance training during haemodialysis. Scandinavian Journal of Urology and Nephrology. 2012(46)

20 Level of Evidence: 3B Summary for: Exercise for the dialyzed: Aerobic and strength training during hemodialysis. Purpose: The purpose of the study was to examine the effects of a combination of aerobic and strength training during dialysis on cardiac fitness, muscle strength, and functional status in end stage renal disease patients. Methods: Twenty-two patients were recruited from the same clinic and screened for eligibility to participate. All underwent a cycle stress test, 600-foot walk test, 6-minute walk test, and the MOS SF-36 health survey before and after 3 months of training. In addition, a one repetition maximum of knee extension was tested before and after training and every 3 weeks so the size of the training weight could be adjusted as the patient progressed in their program. Exercise training was conducted during the first 2 hours of hemodialysis, 2-3 times per week. Three sets of 15 knee extensions were performed with ankle weights correlating to 50% of their one repetition maximum. After strength training, the patient used a Nordic Cycle C5 for 5 minutes followed by a 1 minute rest and repeated this for 30 minutes. The patients were monitored throughout to avoid any adverse events. It was noted that many patients were initially able to perform 5 minutes of cycling and began 1-2 minutes at a time. The training program lasted for 3 months. Results: Eighteen of the 22 patients were able to complete the study. All data that was completed by all 18 patients was analyzed. However, only 14/18 patients performed a post-training stress test and walk test these were not analyzed secondary to so few participants completing these tests. Knee extensor strength and both the physical and mental components of the MOS SF-36 proved to be statistically significant. According to the study, even though the stress test and walk tests were not statistically analyzed, 5 patients showed improvements in aerobic fitness after training. Nine of the 14 patients walked a longer distance after training during the 6-Minute Walk Test, as well. Critique: Although this study showed positive, statistically significant results in knee extensor strength and the MOS SF-36, these results need to be coupled with results from other studies. The study had no control group to compare to, there was a high drop-out rate, not all planned outcome measures were analyzed, and no one was blinded in the study. These factors can potentially affect internal validity and allow a lot of bias to possibly be introduced into the 19

21 study. In addition, the outcome measures shown to be statistically significant are not the best predictors of improved physical performance. More quality studies need to be performed before I would begin to try to implement this type of treatment into practice. Reference: Oh-Park M, Fast A, Gopal S, Lynn R, Frei G, Drenth R, Zohman L. Exercise for the dialyzed: Aerobic and strength training during hemodialysis. Am J Phys Med Rehabil. 2002;81:

22 Summary for: Exercise training during dialysis reduces blood pressure & increases physical functioning & quality of life. Level of Evidence: 3B Purpose: The investigators wanted to research the effects of an intradialytic aerobic exercise program on physical functioning, blood pressure, quality of life, and laboratory data. Methods: Eighteen patients underwent a 24 week protocol. The first 12 weeks were a control phase that began with all patients performing a 6-minute walk test, a 24-hour ambulatory blood pressure monitoring, Medical Outcomes Study 36 Item Short-Form Health Survey (SF-36) questionnaire interview, and blood sample collections. During this control phase (the placebo), the patients performed a 10-minute stretching program of the lower limbs during each dialysis session. During the intervention phase for the last 12 weeks of the study, the patients performed aerobic exercise during dialysis 3 times a week. The patients repeated the tests performed during the control phase to assess any changes that might have occurred during the intervention phase. Results: Fourteen of the 18 patients completed the intervention phase. According to the study, the following were found to have statistically significant improvements mean time able to perform aerobic exercise, physical function (as indicated by 6-Min Walk Test), blood pressure, quality of life (as indicated by physical functioning, social functioning, and mental health portions of questionnaire), and laboratory data (hemoglobin, kt/v, creatinine, LDL, and triglycerides). Critique: This study shows that it may be possible to improve multiple factors of health by performing intradialytic exercise. By looking at the results alone, this seems a very promising intervention to implement. The participants did undergo a control phase, in lieu of having a control group. However, it is still unclear if the participants were blinded as to which phase was the experimental phase. There were many areas of the design that could introduce potential bias that could be improved upon in order to make the study stronger. 21

23 Reference: Reboredo Mde M, Henrique DM, Faria Rde S, Chaoubah A, Bastos MG, de Paula RB. Exercise training during dialysis reduces blood pressure and increases physical functioning and quality of life. Artif Organs Jul;34(7):

24 Summary for: Effect of resistance exercise intradialytic in renal patients chronic in hemodialysis. Level of Evidence: 3B Purpose: The purpose of the study was to study the effects of resistance exercise in the treatment and quality of life of those with chronic renal kidney disease that receive hemodialysis. Methods: 60 patients were divided into 4 groups that contained 15 patients each. Group 1: patients with chronic kidney disease (CKD), diabetes mellitus (DM), & received resistance exercise (RE) program; Group 2: Patients with DM2 + CKD & no RE program; Group 3: CKD + RE program; and Group 4: CKD and no RE program. All patients had the following analyzed at the beginning and end of the study: creatinine, urea, potassium, fasting glucose levels, Kt/V index (for dialysis efficacy), quadriceps manual strength testing, and quality of life (analyzed by the Medical Outcomes Study 36, SF-36). The monitored resistance exercise program occurred 3 times per week for 8 weeks. The RE program consisted of passive stretching of the lower limbs, resistance exercise in major muscle groups, and a relaxation phase. The resistance was individualized for each patient. Results: Since looking at baseline results, only Group 1 was focused on for this paper. There was a significant increase in creatinine that, according to the study, suggests that physical activity was successful in increasing muscle mass. There was a discrete reduction in urea measured in pre and post dialysis. Blood glucose reductions were also statistically significant; however, not enough to modify drug therapy. There was a statistically significant difference in muscle strength, as well as all components of the quality of life questionnaire. Critique: The idea of the design is well-thought out. However, the paper was written in such a vague manner, it was difficult to ascertain the quality of the study. All outcome measures for the group with chronic kidney disease and diabetes mellitus type 2 and receiving the experimental treatment were statistically significant, according to the study. Considering the other studies I have reviewed, I would not expect to see such drastic results in such a short amount of time and with such a small sample size. So, although these results are promising, I would want a more clearly written study that specifies if the participants were blinded, the amount of drop-outs, etc. In addition, I would like to see this study repeated with a larger sample size and for a more extended period of time. 23

25 Reference: Ribeiro R, Coutinho GL, Luras A, Barbosa AM, Camargo de Souza JA, Diniz DP, Schor N. Effect of resistance exercise intradialytic in renal patients chronic in hemodialysis. J Bras Nefrol. 2013;35(1):

26 References: 1. American Kidney Fund (2012). Kidney Disease Statistics. Retrieved from 2. Bohm J, Monteiro Borba M, Saldanha Thome F. Effects of aerobic exercise during hemodialysis in patients with chronic kidney disease: a literature review. J Bras Nephrol. 2012; 34(2). 3. Cheema BSB, O Sullivan AJ, Chan M, Patwardhan A, Kelly J, Gillin A, et al. Progressive resistance training during hemodialysis: Rationale and method of a randomized-controlled trial. Hemodialysis International. 2006; 10: Makhlough A, IIali E, Mohseni R, Shahmohammadi S. Effect of intradialytic aerobic exercise on serum electrolytes levels in hemodialysis patients. Iranian Journal of Kidney Diseases. 2012; 6(2): Bullani R, El-Housseini Y, Giordano F, et al. Effect of Intradialytic Resistance Band Exercise on Physical Function in Patients on Maintenance Hemodialysis: A Pilot Study. Journal of Renal Nutrition. 2011; 21(1): Parsons T L, Toffelmire E B, King-VanVlack C E. Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006;87: Silva SF, Pereira AA, Silva WA, Simôes R, Barros Neto Jde R. Physical therapy during hemodialyse in patients with chronic kidney disease. J Bras Nefrol Jul-Sep;35(3): Chen JLT, Godfrey S, Ng TT, et al. Effect of intra-dialytic, low-intensity strength training on functional capacity in adult haemodialysis patients: a randomized pilot trial. Nephrol Dial Transplant. 2010;25: Ragnarsdottir M, Malmberg E, Strandberg E, Indridason OS. Increased physical fitness among patients following endurance training during haemodialysis. Scandinavian Journal of Urology and Nephrology. 2012(46) Oh-Park M, Fast A, Gopal S, Lynn R, Frei G, Drenth R, Zohman L. Exercise for the dialyzed: Aerobic and strength training during hemodialysis. Am J Phys Med Rehabil. 2002;81:

27 11. Reboredo Mde M, Henrique DM, Faria Rde S, Chaoubah A, Bastos MG, de Paula RB. Exercise training during dialysis reduces blood pressure and increases physical functioning and quality of life. Artif Organs Jul;34(7): Ribeiro R, Coutinho GL, Luras A, Barbosa AM, Camargo de Souza JA, Diniz DP, Schor N. Effect of resistance exercise intradialytic in renal patients chronic in hemodialysis. J Bras Nefrol. 2013;35(1):13-9. Intervention Evidence Appraisal Worksheets Article Search Table Capstone Table of Results Articles Excluded Appendix: 26

28 Name: Christi Hisaw Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Bullani R, El-Housssseini Y, Giordano, F, et al. Effect of intradialytic resistance band exercises on physical function in patients on maintenance hemodialysis: a pilot study. Journal of Renal Nutrition. 2011:21(1): Level of Evidence (Oxford scale): 3B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. Reader s Comments The purpose was stated clearly the goal of the study was to determine the feasibility, safety, and efficacy of an intradialytic resistance band exercise program in prevalent patients on maintenance hemodialysis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study The study discusses why physical activity is important in this population and the barriers they face. It s discussed the different types of exercise that have been studied in the past to find the best type of exercise for this population. The study discusses that intradialytic aerobic exercise has been studied and has shown conflicting results. Resistance exercise has been less studied although the studies reviewed, showed promising results. However, exercising with elastic bands specifically has not been studied in patients on MHD (maintenance hemodialysis). Does the research design have strong internal validity? Appraisal Criterion Reader s Comments 27

29 Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression There are some threats to internal validity because there was no random assignment. Eleven patients gave their consent to participate in the study and all eleven completed the study. The demographics were not too specific; although they did clarify the amount of men/women and their nationality. All participants were greater than 18 years old (from 53-84) and had been on hemodialysis for greater than 3 months (at least 27 months). However, the paper stated the patients were stable, but that is a term that leaves room for interpretation. Their physical function shown by the initial testing of the 4 outcome measures was quite varied. The tests chosen to be measured before and after treatment were objective, but there is potential for the results to be skewed. Are the results of this therapeutic trial valid? Appraisal Criterion 1. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 2. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 3. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? Reader s Comments There was only an intervention group and no control group. So, there was no way to randomly assign the subjects to a group. The potential consequence is that the results could be biased. As stated above, there was only an intervention group. So, it was impossible for the investigators to be blinded unless the investigator was not aware of the design of the study. However, this was not clarified in the paper. This could bias the results since the investigators know all of the participants are receiving the intervention. It could skew their findings. There was no control group to compare to the intervention group. They did report the demographics of the intervention group. According to the outcome measures, their physical function varied quite a bit during the pre-test. The rest of the demographics were varied as well, although there was some basic inclusion criteria. 28

30 4. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 5. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 6. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 7. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 8. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 9. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? It was not clearly stated if the subjects were blinded. So, it is likely the subjects did know that they were receiving the treatment and this could introduce bias into the results because it could affect how hard the patients tried and the amount they participated. It was not specifically stated that the investigators recording the information were blinded. So, it is likely the investigators knew that all of the patients were receiving the treatment and could bias their results skewing the results of the study to show there was a significant change, when in reality there was not. No control group to compare to the intervention group because this was a quasi-experimental study. However, all patients were treated the same within this group for the most part. They all received 2 weekly intradialytic sessions of lower extremity exercises against an elastic band held by a physical therapist. The program included 36 training sessions for 4.5 to 6 months, lasting approximately 40 minutes each and was performed in the first hour of hemodialysis. Three sets of 20 repetitions were performed at a moderate intensity. However, if the patient was tolerating the treatments well, the intensity of the resistance was increased for the last 12 sessions of the program. This leaves room for some error since there is a chance that not all appropriate patients were progressed. The outcome measures were tested immediately following the completion of the entire exercise program which lasted somewhere between 4.5 months to 6 months. This should be an ample amount of time to allow for changes in physical function. All 11 patients that agreed to participate in the study completed the study. Since no patients were lost, nothing had to be done about attrition. Yes, all patients were analyzed in the group they were assigned since there was only one group they could be 29

31 a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? Appraisal Criterion 10. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p- values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here assigned to. Reader s Comments Tinetti Gait & Balance Instrument: /- 3.9 to /- 3.5 (P=.022, Wilcoxson matched-pairs signed rank test). Cohen s d= Effect size (r)= Timed Up & Go Test: /- 6.6 to /- 5.8 (P=.0156, paired t-test). Cohen s d= Effect size (r)= One-Leg Balance Test: / to / (P=.084 Wilcoxon matched-pairs signed rank test). Cohen s d= Effect size (r)= Six-Minute Walk Distance Test: 307 +/- 155m to 351 +/- 176m (+14.5%; P=.0639, paired t test). Cohen s d= Effect size (r)= What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? Based on the calculations of the study, the findings show that it may be possible for my patient to improve her balance and gait, as well as decrease her risk of falls as shown by the Tinetti and the TUG. The One Leg Balance test and the 6-minute walk test were not quite statistically significant in this study; however both showed improvement. For my patient, this means it may be a possible way to exercise during dialysis, as long as medically she is safe. It could also mean making the patient more independent and a decreased fall risk. For my practice, it means that it might be worth looking into more research to implement an intradialytic program if other, higher quality studies show positive results. 30

32 12. Do these findings exceed a minimally The MCID was not brought up or discussed. important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 13. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 14. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 16. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? Reader s Comments Currently, this intervention would not be appropriate for this particular hospital setting. Some collaboration would need to be done with the dialysis clinic in order to make room for possible equipment and ensure that extra staff is allowed in the clinic. Also, the 3 rd party coverage is not currently available. However, if this was proven to be a safe, effective treatment, I believe the hospital would change to accommodate this treatment option. The patient was in the age range of and had been on dialysis at least as long as the patients in this study (at least 27 months). However, most of the patients in this study were men. These demographics are still somewhat vague, especially because they referred to these patients as stable and did not elaborate. I could use this intervention only if combined with a lot other data to make an informed, educated decision if this is a safe, viable option for her. I don t think the patient was medically stable enough to implement this intervention and the potential benefits do not outweigh the risks. I believe this would have needed to have been implemented when first starting dialysis in order to be safe. However, for more stable patients as long as they were extremely closely monitored and cleared by their physician, it might be an option worth trying. I do think more research needs to be done in order to decipher what to monitor and what red flags to watch out for during intradialytic exercise. The patient was willing to participate in physical therapy when she was available. However, this was not always possible. She requested elastic bands at discharge. So, I believe this intervention would fit with her values and expectations as long as it was safe. 31

33 17. Are there any threats to external validity in this study? No external events took place that I was aware of to affect the results. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Reader s Comments 3/10 and eligibility criteria was specified, even if it wasn t very specific. Summarize your findings and relate this back to clinical significance It was shown, in this pilot study, that it is possible to implement an intradialytic program safely in hemodialysis patients to successfully increase physical function in this population. Due to the small sample size and lack of control group, these findings do need to be taken with caution. However, this is encouraging for future studies and the possibility of intradialytic exercise programs becoming a regular part of hemodialysis. 32

34 Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study please calculate the CER, EER, RBI/RRR, ABI/ ARR and NNT) + outcome - outcome a b + intervention c d - intervention CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) = Relative risk reduction (RRR) CER EER CER EER CER Absolute risk reduction (ARR) CER-EER Number needed to treat (NNT) 1/ARR Relative benefit increase (RBI) Absolute Benefit Increase (ABI) Number needed to treat (NNT) 33

35 CER EER EER CER CER EER-CER 1/ ABI Pedro Scoring System: 34

36 Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

37 Name: Christi Hisaw Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Parsons T L, Toffelmire E B, King-VanVlack C E. Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006;87: Level of Evidence (Oxford scale): 3B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. Reader s Comments This study clearly states its purpose is to assess the impact of a 20-week intradialytic exercise program (consisting of 60 minutes of cumulative duration, lowintensity exercise during the first 2 hours of dialysis) on dialysis efficacy, physical performance, and quality of life. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study The paper discusses the physiological issues patients with end-stage renal disease face as a result of their disease, and discuss the fact that exercise helps to decrease these issues. Most studies look at the effects of exercise done between dialysis sessions. However, performing exercise during dialysis might not only improve physical function and quality of life, but also efficacy of dialysis. According to this study, few studies have measured the acute or long-term effects of intradialytic exercise on urea removal and dialysis efficacy in vivo. In addition, the study explains that to date no study has shown for sure that an intradialytic exercise program can result in serum urea clearance which is the current clinical standard to establish dialysis efficacy. Does the research design have strong internal validity? 36

38 Appraisal Criterion Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Reader s Comments This study did not contain a control group and only 13 out of 20 patients completed the entire study. Both of these factors could potentially threaten internal validity. Patients were required to have been receiving hemodialysis for at least 6 months and had to be older than 18 years old. In addition, nephrologists determined if a patient was too medically complicated to participate in the study. Serum urea clearance was measured from a blood sample and calculated by using 2 different formulas established by previous studies. The reason for this was because one formula is only shown to give valid results in a certain range and the patients improved beyond that range. The six minute walk test was used to measure physical function. Quality of life was measured by a self-report questionnaire. The data from those that withdrew from the study was not analyzed since they withdrew extremely early on in the study; however, each patient was accounted for in regards to the reasons that they withdrew from the study. Are the results of this therapeutic trial valid? Appraisal Criterion 18. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 19. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 20. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what Reader s Comments The investigators did not randomly assign patients as there was only an experimental group. This could possibly skew the results since the patients were picked specifically to be in this group. The investigators recruited a total pool of 50 people and 20 of which agreed to participate. The investigators were aware of the patients who signed up to be in the experimental group. This could skew the results because they could have recruited patients they think would have positive results. All of the patients in the experimental group had to meet certain inclusion criteria, but there was no control group to compare to. They did report a detailed description of demographics of those involved in the study. However, 37

39 differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 21. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 22. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 23. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 24. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 25. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? not having a similar control group could skew the results because there isn t anything to compare the patients change to. The subjects did know they were receiving treatment; however, it is unclear if the investigators informed the patients they were the only group involved in the study. However, if the patients were aware of this, they might fill out the self-report form in a biased manner or try harder on the 6-minute walk test in order to have more positive results. The investigators were in charge of recruiting patients. There was only one group. So, the investigators knew that all of the patients were receiving the treatment. This could bias the results because they may unintentionally or intentionally skew the results because they know how to manipulate the data. All patients received 2 30-minute bouts of exercise with a 30 minute rest in between during the first 2 hours of physical therapy. Blood pressure and heart rate were monitored throughout. However, patients either used a weighted cycle ergometer or a mini stepper. In addition, subjects selected their own exercise intensity so they could comfortably complete the 30 minute bouts of exercise. This could skew the results because not all patients were using the same equipment and some patients might push themselves more than others during exercise. Also, all patients had blood samples drawn to estimate the serum urea clearance every 4 weeks. Lastly, all patients performed the 6-minute walk test at baseline, at week 10, and at week 20. The follow-up time occurred in the final week of the study. In addition, the study lasted for 5 months. This should be ample time to allow for changes in physical function. Not all the subjects completed the study. Originally, 20 were enrolled, but only 13 completed the study so 7 were lost. The authors did nothing about the attrition except clarify the reasons for the drop-outs. Their data 38

40 c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 26. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? Appraisal Criterion 27. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p- values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here was not analyzed. It was stated later in the paper that the investigators chose to keep the 13 subjects into one group to keep the sample size higher instead of breaking them into 2 groups (one of 6 and one of 7) in order to have a control group. They decided that one group of 13 would be better for statistical analysis. So, the drop-outs must have occurred before the actual experiment began. All patients were analyzed in the group to which they were assigned because there was only one group. Reader s Comments According to the study, in regards to serum urea clearance, the two formulas both found the intervention to be statistically significant. Jindal formula: Significant difference as compared with the respective control value at p <.05 Baseline: / Week 20: / Daugirdas formula: Significant difference as compared with Jindal value at the same time point at p <.05. Baseline: / Week 20: / * This translated into an 11% increase in serum urea clearance in the first month and remained elevated throughout treatment at 18-19%. Six Minute Walk Test: Baseline: 520 +/- 101 m 10 Weeks: 593 +/- 95 m 20 Weeks: 593 +/- 108 m *This translated into an approximate 14% improvement in functional performance at the end of 20 weeks compared to baseline. *A weak correlation (r=.32, p <.06) was found between the 6-MWT and the serum urea clearance. 39

41 Quality of Life: No significant differences were found in the self-reported QOL questionnaires. 28. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? Serum urea clearance increased significantly indicating an increase in dialysis efficacy and the 6 minute walk test was statistically significant indicating an improvement in physical function. This study indicates not only could exercise during dialysis potentially improve physical function, but also the efficacy of dialysis for my patient. 29. Do these findings exceed a minimally No, the MCID was not discussed in this paper. important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 30. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 31. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 32. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 33. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? Reader s Comments It would take a lot of change to set up this type of exercise program in a dialysis clinic. It would not be readily available or affordable since it requires trained staff for supervision and expensive equipment. 5/13 were women. 6/13 had hypertension. 2/13 had diabetes mellitus. The majority of these patients were not that similar to my patient other than the fact they all require hemodialysis. I might be able to use this intervention despite the differences; however, I would want to do more research to ensure this is a safe intervention for patients with many co-morbidities. Based off this study, I am unsure the potential benefits outweigh the potential risks and therefore I would take the cautious route and not try this with my patient until I find more definitive research. She was not as medically stable as I would like her to be before implementing this type of intervention. The intervention would fit within my patient s values and expectations since she was eager to return to her prior level of function and was always willing to work with physical therapy. 40

42 34. Are there any threats to external validity in this study? No external events took place that I was aware of that would affect external validity. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Reader s Comments 3/10 and eligibility criteria was specified. Summarize your findings and relate this back to clinical significance In this study, patients performing self-paced aerobic exercise during the first 2 hours of dialysis were shown to significantly improve their physical function and efficacy of dialysis. This could potentially impact the way I treat my patients; however, I would want a more definitive study performed with a much larger sample size. If I was to make a decision off of this study alone, I would not choose to use this on a patient with an extremely low activity tolerance. These patients were more medically stable than my patient. In addition, these patients were able to perform 60 minutes of exercise in 90 minutes. My patient was not at the level that she could participate that much. According to the researchers, after extensive investigation, they chose low-intensity and a longer duration of exercise in order to optimally target the serum urea clearance. So, I would want maintain these exercise parameters. If I were to choose to attempt to implement this as a treatment, I would only consider a more medically stable patient that is able to handle this duration of exercise. Also, I would want a complementary study of higher quality with similar or even more improved results before seriously considering implementing this treatment. 41

43 42

44 Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study please calculate the CER, EER, RBI/RRR, ABI/ ARR and NNT) + outcome - outcome a b + intervention c d - intervention CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) = Relative risk reduction (RRR) CER EER CER EER CER Absolute risk reduction (ARR) CER-EER Number needed to treat (NNT) 1/ARR Relative benefit increase (RBI) Absolute Benefit Increase (ABI) Number needed to treat (NNT) 43

45 CER EER EER CER CER EER-CER 1/ ABI Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

46 Name: Christi Hisaw Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format: Silva SF, Pereira AA, Silva WA, Simôes R, Barros Neto Jde R. Physical therapy during hemodialyse in patients with chronic kidney disease. J Bras Nefrol Jul-Sep;35(3): Level of Evidence (Oxford scale): 3B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Reader s Comments The purpose of this study was to evaluate the benefits of a 16 month long intradialytic exercise program. Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study There is a huge increase in the prevalence in those with kidney disease who require hemodialysis. Some studies have discovered significant reductions in the quality of life in patients with chronic renal failure receiving hemodialysis and are related to changes in muscle structure and function resulting in weakness and decreased aerobic performance. Physical activity is an important factor in helping to decrease symptoms and various complications patients in this population experience. Exercise contributes to prevent, as well as delay progression in patients with kidney disease. Despite the fact need for research on this topic, little research has been performed. So, this study was designed to address that. 45

47 Does the research design have strong internal validity? Appraisal Criterion Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Reader s Comments Patients with more complicated medical histories, such as those with severe cardiovascular diseases or possible severe heart disease were excluded from the study. All patients had at least one comorbidity diabetes mellitus accounting for 21% of the patients. The study did not mention if any patient had to drop out of the study. All 56 patients were in the experimental group and there was no control group to compare to. This rules out any compensatory rivalry, but this also means that the investigators and patients could not be blinded. However, the amount of patients in the experimental group was of good size. All patients were treated in the same fashion. Are the results of this therapeutic trial valid? Appraisal Criterion 35. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 36. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 37. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How Reader s Comments The investigators did not randomly assign subjects because all 56 patients received the experimental treatment. This makes it possible for the results to be skewed because investigators could place patients they believe would produce positive results. However, all patients were in the experimental group. Since all patients received the experimental treatment, the investigators knew which group they were assigned to. This could skew the results whether intentionally or unintentionally by the investigators. There was no control group to compare to the experimental group. They did report the demographics of the subjects. 46

48 might the differences between groups affect the results of the study? 38. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 39. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 40. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? Since the subjects all received the treatment, the subjects had to know which group they were assigned to. This could skew the results because the patients may behave differently knowing they are in the experimental group compared than they would if it was blinded. The investigators had to know which group the subjects were assigned to since there was only one group. This might tempt the investigators to skew the results in a positive manner, whether intentionally or unintentionally, to produce the results they want to see. All of the patients received the same treatment. The participants were assessed before and after the training protocol using the Medical Outcomes Study Short- Form 36 (SF-36) questionnaire, The BORG scale of the perceived exertion level, 6-minute walk test, and through the manual muscle strength testing of 1 maximum repetition for knee extensors. Physical therapy sessions were performed for 20 minutes and respiratory rates, heart rates, and blood pressure were checked before and after therapy sessions. The exercises were performed 3 times per week for 16 months during the first 2 hours of hemodialysis. Exercise program consisted of: 10 minutes on the stationary bike, strengthening the upper and lower limbs with weights, medicine ball, and theraband and passive static stretching exercises. 41. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 42. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? The subject follow-up was 16 months after the study began. This is an ample amount of time for the patients to adjust to the treatment, the physiological changes to occur, and to get an accurate picture about the patients physical function. The study did not specifically state if any of the patients did not complete the study. So, if any did drop out, it s also unknown if the authors did anything about the attrition. If there were dropouts, there is the possibility the results could be skewed depending on the reason for the dropout. 43. Were all patients analyzed in the groups to Because the study does not say if there were patients 47

49 which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? Appraisal Criterion 44. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p- values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here who dropped out of the study, there is no way to know if all of the patients were analyzed. This could make the results look positive when they truly are not if not all the data is analyzed. Reader s Comments Domains of the SF-36 Questionnaire, before & after 16 months in the physical therapy program Domains Before After p Functional capacity ± Limitations by physical aspects ± Pain ± General health status ± Vitality ± Social aspects ± Emotional aspects ± Mental health ± ± ± ± ± ± ± ± ± Variables before & after PT in regards to the 6 minute walk test (TC6M) Heart rate: Before TC6M After TC6M Mean before PT / / Mean after PT / / P = Respiratory Rate: Before TC6M After TC6M Mean before PT / / Mean after PT / /

50 P= Systolic Blood Pressure: Before TC6M After TC6M Mean before PT / / Mean after PT / / P= Diastolic Blood Pressure: Before TC6M After TC6M Mean before PT / /- 2.6 Mean after PT / /- 2.3 P= Distance Traveled in the 6-Minute Walk Test Mean before PT: / Mean after PT: / P= Strength testing for quadriceps Before PT: Minimum 3- Maximum 4 After PT: Minimum 4 Maximum 5 P= < Borg Scale after 6 minute walk test Initial: Mean= / and median= 0.50 Final: Mean= / and median= 0.50 P= < What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? For quality of life, there was only a statistically significant improvement in the areas of functional capacity and pain. The heart rate and respiratory rates (at the end of the 6- minute walk test) before and after the program test are statistically significant meaning these rates could improve with training. However, there was no significant change in blood pressure, but it did stay constant. The Borg Scale scores and the 6 minute walk tests were also shown to be statistically significant indicating that patients were less tired after walking a longer distance in the 6 minute walk test. These results indicate that an exercise program might help increase the quality of life, the physical function, and help improve some physiological factors for my patient. Since patients on hemodialysis are so prevalent, this 49

51 means I could potentially use this approach for many of my patients. 46. Do these findings exceed a minimally No. This was not brought up or discussed. important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 47. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 48. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 49. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 50. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 51. Are there any threats to external validity in this study? Reader s Comments This intervention does not sound like it would be easily available or affordable; however, I believe a program could eventually be developed. All of the subjects have at least one comorbidity. The median age is about 20 years younger than my patient. There were a fair amount of women included in this study. However, I still think my patient has more complicated medical issues secondary to recent events. I don t think I could use this intervention knowing she is more medically involved than these patients. The potential benefits do not outweigh the potential risks with my patient because of her extensive medical complications. The intervention does fit with my patient s goals and expectations. She s always willing to participate in physical therapy and is willing to do what she needs to do to become more independent again. No. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Reader s Comments 3/10 and eligibility criteria was specified. 50

52 Summarize your findings and relate this back to clinical significance The results of this study indicate that a long term intradialytic exercise program could help to improve physical function, patient perceived exertion levels and quality of life for patients receiving hemodialysis. Although the number of patients that participated in this study was high, there was no control group to compare the results to only the pre- and post-tests of the participants. These patients all had at least one comorbidity including diabetes mellitus (21%) which many studies have chosen to exclude. However, the patients still appeared to have less complicated medical histories and are more able to participate in physical activity compared to many of the patients being treated in the hospital. So, while these results are encouraging, I believe more research would need to be done in order to decipher what patients are most appropriate for these exercise programs and if they are truly effective. 51

53 Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study please calculate the CER, EER, RBI/RRR, ABI/ ARR and NNT) + outcome - outcome a b + intervention c d - intervention CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) = Relative risk reduction (RRR) CER EER CER EER CER Absolute risk reduction (ARR) CER-EER Number needed to treat (NNT) 1/ARR Relative benefit increase (RBI) Absolute Benefit Increase (ABI) Number needed to treat (NNT) 52

54 CER EER EER CER CER EER-CER 1/ ABI Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

55 Name: Christi Hisaw Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Chen JLT, Godfrey S, Ng TT, et al. Effect of intra-dialytic, low-intensity strength training on functional capacity in adult haemodialysis patients: a randomized pilot trial. Nephrol Dial Transplant. 2010;25: Level of Evidence (Oxford scale): 3B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. Reader s Comments The purpose of this study was to examine the safety and efficacy of an intradialytic, low-intensity progressive strength training program for hemodialysis patients. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study The number of patients with kidney failure treated by dialysis and transplantation in the USA has increased by 57% in the last decade. Long-term dialysis extends the life of these patients, however, their quality of life and physical function tends to be low. In addition, poor physical performance is associated with higher risk of death and hospitalization among dialysis patients. It has been shown that moderate- to high- intensity strength training improves physical performance, muscle mass, and quality of life in chronic kidney disease and dialysis patients. However, older patients may not be able to tolerate this intensity of exercise. So, the investigators wanted to examine the effects of an intradialytic, lowintensity exercise program on functional capacity. Does the research design have strong internal validity? 54

56 Appraisal Criterion Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Reader s Comments All of the patients were recruited from the same 2 clinics. This might indicate it is not a good representation of the general population. The inclusion and exclusion criteria were stated. Patients were randomized into one of two groups strength training or stretching exercises (as an attention control group). However, there was a large dropout rate between 36 and 48 sessions, that according to the study, was due to illness and hospitalization. However, this occurred equally in both groups and there was enough data from previous testing that could be carried forward. However, this could be considered a threat to internal validity if many were unable to complete the entire study. This study was aimed at older hemodialysis patients, so this might not have been able to be avoided. It is possible that the instrument used were not the most accurate way of measuring lean and fat body mass or they could not have been calibrated correctly. Also, self-reported questionnaires aren t always the most reliable way of getting information either; however, it is hard to assess quality of life any other way. Are the results of this therapeutic trial valid? Appraisal Criterion 52. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 53. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 54. Were the groups similar at the start of the trial? Did they report the demographics of Reader s Comments Yes, the investigators randomly assigned patients to one of two groups a strengthening group or a stretching group that was used as an attention control group. This random assignment should help to decrease some possible bias that could be introduced into the study otherwise. The investigators did not know who was being assigned to the groups prior to the allocation. According to the study, the sociodemographic or clinical characteristics between participants enrolled and those 55

57 the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 55. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 56. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 57. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 58. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 59. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? refusing to participate were no different. In addition, there were no differences between patients assessed for eligibility or among those who were randomized and dropped out before the intervention. Lastly, according to the study, there were no differences in baseline characteristics between the experimental group and the attention control group, except for a trend toward shorter a shorter amount of time having been on hemodialysis in the strength training group. A detailed table was presented to show the similarities in sociodemographics, physiological characteristics, and the clinical characteristics. The patients did know which group they were assigned to because the investigators were unable to blind them. This opens the potential for bias because this knowledge may affect the subjects performance. The study did state that it was not feasible to blind the testers. So, yes they did know the group the subjects were assigned to, which could possibly introduce bias into the study, whether intentional or unintentional, and skew the results. The groups were managed equally apart from the actual experiment treatment. The subject follow-up time was sufficiently long enough to allow for changes in physical function, strength, and quality of life to occur. So, the length of time would allow the researchers to answer their question. No. Not all of the subjects that enrolled in the study were able to complete the study; however, the researchers did account for and adjust for these dropouts. It s important to note that at the start of the study, they had intended to use the final-testing (48 weeks) SPPB score for the primary outcome, but based on the number of interruptions in training due to patient illnesses or hospitalizations, they decided to use the post-testing SPPB score instead and to carry forward mid-testing score data as necessary. The change in analysis plan was made 3 months into the study, prior to examination 56

58 of any outcome data and with concurrence of the Data Safety Monitoring Board. Analyzing the data after 36 sessions, instead of 48 allowed for many more subjects to have their data analyzed. Only 6 patients did not have any mid- or post- testing data to carry forward and therefore, were not analyzed. There is a possibility the results could have been skewed; however, the rates at which subjects dropped out were similar in both groups indicating that the intervention was not the reason for the dropouts 60. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? In the strength group, 19 patients completed pre/posttesting (36/48 weeks) and 3 patients had mid-testing data carried forward. In the control group, 20 completed pre/post-testing (36/48 weeks) and 2 patients had midtesting data carried forward. There were only 6 people (3 in each group) that were not analyzed secondary to not having either mid- or post- testing data to carry forward to analyze. Are the valid results of this RCT important? Appraisal Criterion 61. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p- values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here Reader s Comments The primary outcome was physical performance based off of the SPPB (Short Physical Performance Battery) score, which includes five chair stands (strength), 4-m gait speed (endurance), side-by-side, semi-tandem, and tandem (balance). Scores less than 7 have been shown to be prognostic of disability, institutionalization, and death. Secondary outcomes were as follows: knee extensor strength, lean and fat mass, self-reported quality of life, and self-reported disability. Primary outcome: SPPB post-testing scores were statistically significant in regards to strength when comparing the strength group to the attention control group 21.1% (43.1%) vs. 0.2% (38.4%), respectively, P=0.03. The strength training group was able to decrease their chair stand time and the attention control group s time worsened: /- 43.4% vs /- 34.5%, P=0.04. However, balance and gait did not change in either group. Secondary outcomes: knee extensor muscle strength 57

59 significantly improved with the strength training group compared to the controls 44.9% (26.3) vs -18.1% (17.9), respectively, P= Whole-body lean mass increased significantly for the strength group compared to the control group 4.2%(5.6) vs. -3.2%(3.3), respectively, P= Fat mass significantly decreased in the strength group compared to the control group 5.0%(7.6) vs -3.2(5.8), respectively, P= Self-reported physical activity increased significantly for the strength group compared to the control group 10.3%(88.1) vs -30.5(34.3), respectively, P= The physical component on the SF-36 also showed significant improvement for the strength group compared to the control group 21%(36) vs -2%(24), respectively, P= Lastly, self-reported ADL disability also showed statistically significant results for the strength group compared to the control group 10.5%(21.1) vs - 2.6%(8.0), respectively, P= What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? 63. Do these findings exceed a minimally important difference? Was this brought up These statistical findings indicate that my patient may improve in physical function, quality of life, increase lean mass, and decrease fat mass using a low-intensity intradialytic exercise program, as opposed to a mid- or high-intensity program. This is encouraging because my patient was older and was not able to perform higher intensities of exercise. In addition, other studies have not looked at fat and lean mass. So, it is nice to have this information in addition to physical function. I do appreciate that they used an attention control group so there could be more of a comparison between groups of people and not just pre- and post- test changes in the same group. However, the amount of dropouts between weeks 36 and 48 due to illness and hospitalization concerns me even though I know the patient population in this study was older and the study claims the adverse events were not a result of the training program. In addition, with the study design, a fair amount of bias could have been introduced. So, while I will keep this information in mind, I don t know that this type of intervention is appropriate for every patient, if any at all. No. This was not brought up or discussed. I will keep this 58

60 or discussed? evidence in mind. a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 64. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 65. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 66. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 67. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 68. Are there any threats to external validity in this study? Reader s Comments This intervention does not sound easily available in the current clinical setting. However, with some work, I think an intradialytic program could be created should this prove to be a truly effective treatment. My patient was actually younger than the mean age in either group. About half of the subjects in the study were women; however, almost none of them were Hispanic. Although, a fair amount of the patients did have diabetes and hypertension and had multiple medications. Looking at all of the data, I would say she was relatively similar to these patients. A fair amount of patients had been hospitalized in the 12 months prior to enrollment and had multiple chronic conditions. So, although I do not know for sure if my patient was hospitalized in the past year and I m not sure her account of her medical history was complete (this was her first time being treated by our hospital) these patients seem more medically complicated compared to other studies and are probably more similar to my patient at least in comparison to other studies. These investigators did not allow the patients to participate in the study if they had been hospitalized in the 6 months prior to the study beginning. So, although these patients seem to have a fair amount of medical complications, they were still more stable than my patient was. I do not believe the potential benefits outweigh the potential risks in this situation. This intervention would fit with my client s stated goals and expectations. She was willing to perform any exercise that would increase her independence and chances of returning home. No external events occurred that I am aware of that could have affected the results of this study. 59

61 What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) Reader s Comments 6/10 and eligibility criteria was stated. Summarize your findings and relate this back to clinical significance These findings suggest that it may be beneficial to implement an intradialytic low-intensity exercise program as part of routine care in dialysis units since this study found that it improved physical performance, nutritional status, and physical activity in an older population on hemodialysis. It is encouraging to know that even lowintensity exercises could have a significant effect on physical function and quality of life in the elderly population. However, given the design of the study and the amount of patients only able to finish 36/48 weeks, I would like to take these results with caution. The amount of people unable to finish was similar in both groups, which is a little more encouraging that these adverse events were not secondary to the training program. I don t know that I would find these results clinically significant until more research has been done with a larger sample size. 60

62 61

63 Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study please calculate the CER, EER, RBI/RRR, ABI/ ARR and NNT) + outcome - outcome a b + intervention c d - intervention CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) = Relative risk reduction (RRR) CER EER CER EER CER Absolute risk reduction (ARR) CER-EER Number needed to treat (NNT) 1/ARR Relative benefit increase (RBI) Absolute Benefit Increase (ABI) Number needed to treat (NNT) 62

64 CER EER EER CER CER EER-CER 1/ ABI Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

65 Name: Christi Hisaw Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Ragnarsdottir M, Malmberg E, Strandberg E, Indridason OS. Increased physical fitness among patients following endurance training during haemodialysis. Scandinavian Journal of Urology and Nephrology. 2012(46) Level of Evidence (Oxford scale): 3B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Reader s Comments The purpose of this study was to examine the effects of a moderate intensity, endurance training exercise program during dialysis for 6 months on physical performance and the risk of falling in hemodialysis patients. This paper discussed the poor health of those with chronic kidney disease and end-stage renal disease (ESRD) secondary to their complicated medical histories. It was stated that patients with ESRD beginning dialysis, their physical fitness has been shown to be only about 50% of that compared to a person of the same age and gender. In addition, hemodialysis does not filter as well as the kidneys resulting in metabolic derangements that further assist in decreasing the physical fitness in these patients. It has been shown that patients with ESRD can increase in physical fitness, quality of life, among other related aspects performing high-intensity training. Intradialytic exercise has gained popularity compared to non-dialysis exercise because it may increase exercise compliance and it is thought that the exercise helps to facilitate the removal of urea and other waste products from the tissues and into the bloodstream secondary to an increase in blood flow, allowing more waste products 64

66 to be filtered during dialysis. This study, as stated above, wanted to address the effects of moderate intensity exercise on patients receiving hemodialysis. Does the research design have strong internal validity? Appraisal Criterion Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Reader s Comments All of the patients were recruited from the same hospital in Iceland indicating this might not be a good sample of the general population. Also, the assignment was not random so neither the subjects, nor the researchers could be blinded. There was a high attrition rate, but the researchers did account for each individual reason for the dropouts. Out of the 21 participants, 9 were not able to finish 3 months of training. Out of the remaining 12, 3 did not finish 6 months of training. This population, secondary to their deconditioned state, is more likely to suffer adverse events. It was reported the patients history was documented and analyzed; however, it was not described in detail which also could affect internal validity. The tests they chose to measure physical performance are objective in nature; however, they were performed pre-training, at 3 months, and at 6 months. I do believe that 3 months is a long enough interval that a learning curve could not be developed, however, it could be possible, which would affect internal validity. Overall, I would say their internal validity may not be all that strong. Are the results of this therapeutic trial valid? Appraisal Criterion 69. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 70. Did the investigators know who was being assigned to which group prior to the Reader s Comments No, the subjects were not randomly assigned which could introduce some bias into the study secondary to potentially targeting patients who are expected to receive positive results, thus skewing the results. The investigators did know who was being assigned to 65

67 allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 71. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 72. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 73. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 74. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 75. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? the experimental group prior to allocation since there was only one group. This could also skew the results because the researchers could intentionally or unintentionally skew the results just by knowing this information. There was no second group to compare to. In addition, the study reports that descriptive statistics were used to analyze the demographic data; however, none of it was shown in the paper. Only the exclusion criteria was stated for the patients which was as follows: patients who had been hemodialysis for less than 3 months and those who were unable to walk 50 m with or without walking aids. The subjects did know which group they were being assigned to which could also introduce bias. This could affect the effort the patients put forth. The investigators did know which group all of the patients were assigned to which could also allow for bias to be introduced into the study whether intentionally or unintentionally. It seems as though all patients received the same treatment. All patients, prior to the treatment beginning, underwent a 6-minute walk test, timed up and go, timed stand test, and Romberg s test. The Borg scale was also utilized during these tests to assess perceived exertion. The exercise sessions consisted of training on a bicycle while confined to a bed. The session took place during the first half of the treatment. Vital signs were recorded before the training session, after 5 and 15 minutes, and at the end of training. Patients, again, were asked to use the Borg scale to monitor perceived exertion. The intensity aimed for was on the Borg scale. The exercise time did vary anywhere from 12 minutes to 40 minutes based on the individual s capacity. Even though the high attrition rate did not allow for most of the patients to finish the study, I believe that 3 months is enough time to allow for physiological changes that would affect physical performance and balance which most of the patients were able to complete. In addition, some of the patients did complete all 6 months of the 66

68 study allowing for more time for these changes to occur. 76. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 77. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? No, as mentioned and explained in previous questions, not all patients originally enrolled in the study were able to complete it. 9 out of 21 subjects were unable to complete the first 3 months of the study, and 3 of the remaining 12 were unable to complete the last 3 months of the study. The researchers did not replace All 12 of the patients that completed at least 3 months of the study were analyzed together. Then, the remaining 9 that were able to complete the entire study were also analyzed. So, the data from all of the patients that completed the 3 months was not carried forward, but still analyzed separately. So, yes, all of the patients were analyzed. Are the valid results of this RCT important? Appraisal Criterion 78. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p- values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here Reader s Comments 12 participants able to finish 3 months: 6-Min Walk Test (m) Baseline: 275(90-452) 3 Months: 320 ( ) p value: TUG (s) Baseline: 13 ( ) 3 Months: 10.8 ( ) p value: Timed Stand Test Baseline: 44.0 ( ) 3 Months 36.4 ( ) p value: patients able to complete study: 6-Min Walk Test (m) Baseline: 250 (90-432) 6 Months: 305 ( ) p value: TUG (s) 67

69 Baseline: 13 ( ) 3 Months: 10.9 ( ) p value: Timed Stand Test Baseline: 44 ( ) 6 Months: 33.7 ( ) p value: What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? The calculations done by the study show that the participants that were able to complete the study improved significantly in all 3 tests that were used to measure physical function. Just looking at the statistics makes the intervention sound promising; however, there are a lot of other factors to take into consideration. 80. Do these findings exceed a minimally The MCID was not discussed in this paper. important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 81. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 82. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 83. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? Reader s Comments The intervention sounds appropriate to use in the clinical setting; however, a program would need to be set up. The facility doesn t currently have the time or coverage to introduce this type of treatment into the facility quite yet. Other than the fact that these patients have been receiving dialysis for greater than 3 months, I do not know any other demographic information. So, I m unsure how similar my patient is to the patients being evaluated in this study. Criteria did state the inability to walk 50m with or without an assistive device would exclude them from the study. I can derive from this information that they were higher functioning than my patient was during the evaluation. I could only use this information in combination with the information from other studies. The benefits do not outweigh the risks. A lot of the patients in this study suffered adverse events and considering the complex medical history of my patient I 68

70 would not use this intervention with her. 84. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 85. Are there any threats to external validity in this study? This intervention did fit with my patient s values because she was willing to perform any exercise that would help to increase her physical function in order to allow her to go home. There is a possibility of a biased sample collection since they were all screened form the same clinic. Their inclusion criteria were not very strict, which could allow for a more generalized sample. The authors do report no conflicts of interest. What is the bottom line? Appraisal Criterion Reader s Comments PEDRO score (see scoring at end of form) 2/10 Eligibility Criteria was specified. Summarize your findings and relate this back to clinical significance Although this study showed the intervention to be statistically significant in all 3 measures used to look at physical function, given all of the variables amount of bias that could possibly be introduced into the study and the high attrition rate secondary to adverse events I don t believe this has clinical significance. A lot more high quality studies need to be done before I would say this treatment has clinical significance as well as statistical significance. 69

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72 Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study please calculate the CER, EER, RBI/RRR, ABI/ ARR and NNT) + outcome - outcome a b + intervention c d - intervention CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) = Relative risk reduction (RRR) CER EER CER EER CER Absolute risk reduction (ARR) CER-EER Number needed to treat (NNT) 1/ARR Relative benefit increase (RBI) Absolute Benefit Increase (ABI) Number needed to treat (NNT) 71

73 CER EER EER CER CER EER-CER 1/ ABI Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

74 Name: Christi Hisaw Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Oh-Park M, Fast A, Gopal S, Lynn R, Frei G, Drenth R, Zohman L. Exercise for the dialyzed: Aerobic and strength training during hemodialysis. Am J Phys Med Rehabil. 2002;81: Level of Evidence (Oxford scale): 3B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. Reader s Comments The purpose of the study was to examine the effects of a combination of aerobic and strength training during dialysis on cardiac fitness, muscle strength, and functional status in end stage renal disease patients. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study This paper discusses that it is well-known that patients with end stage renal disease are a very deconditioned population and how this significantly decreases their quality of life. It also discusses that previous studies primarily focus on aerobic training exercise programs. The researchers stated there was a need to study strength training, in addition to aerobic exercise. Also, the researchers used a cardiac stress test and a walk test as outcome measures for functional performance. The researchers reported the use of a functional cardiac stress test would allow for more precise exercise programming and quantitative assessment of outcome because it is used to determine exercise capacity and cardiopulmonary response. 73

75 Does the research design have strong internal validity? Appraisal Criterion Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Reader s Comments All of the patients were recruited from one clinic. This could introduce bias into the study because this sample may not be a good representation of the general population. There was equipment used during the stress test that could have also affected the results if, for some reason, it malfunctioned or was not calibrated correctly. In addition, the 1 repetition maximum for knee extension was performed every 3 weeks over a period of 3 months. This could have allowed the patients to become familiar with the test and skewed the results since they knew what to expect. There was no control group so there could not have been compensatory equalization of treatments or compensatory rivalry. I don t believe there were any issues with statistical regression. Are the results of this therapeutic trial valid? Appraisal Criterion 86. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 87. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 88. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the Reader s Comments There was only one group so they could not be randomly assigned. All 22 patients received the treatment. Since there is no control, this could introduce bias into the study and skew the results making it appear as if the treatment was effective, when in reality it was not. The investigators knew who was being assigned to the group prior to allocation because there was no control group this could also introduce bias into the study since they know each patients is receiving the treatment they could intentionally or unintentionally skew the results. The demographics of the patients were mentioned very briefly. They stated the average age was 52 years old (range, 24-84), the male-to-female ratio was 10:12. In addition, the etiologies of ESRD included diabetes, hypertension, lupus, polycystic kidneys, obstructive nephropathy, renal cell carcinoma, and glomerulonephritis. This was all the information that was given and it was not in chart form only the description 74

76 study? 89. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 90. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 91. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 92. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 93. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? stated above. Yes, the subjects all knew that they were receiving the treatment. This could affect the way they participate during and outside of the study and could possibly affect internal validity. The investigators did know all of the patients were receiving the treatment. So, it was not feasible to blind them. This also affects the internal validity since the investigators could potentially make the results appear as they want them to appear. All of the patients underwent a cycle stress test, 600-foot walk test, 6-minute walk test, and the MOS SF-36 health survey before and after 3 months of training. In addition, a one repetition maximum of knee extension was tested before and after training and every 3 weeks so the size of the training weight could be adjusted as the patient progressed in their program. Exercise training was conducted during the first 2 hours of hemodialysis, 2-3 times per week. Three sets of 15 knee extensions were performed with ankle weights correlating to 50% of their one repetition maximum. After strength training, the patient used a Nordic Cycle C5 for 5 minutes followed by a 1 minute rest and repeated this for 30 minutes. The patients were monitored throughout to avoid any adverse events. It was noted that many patients were initially able to perform 5 minutes of cycling and began 1-2 minutes at a time. The training program lasted for 3 months. This should be an adequate amount of time for physiological changes to occur in order to assess a change in functional performance. Eighteen of the 22 patients were able to complete the study. The 3 patients that did not complete the program dropped out secondary to unrelated medical problems (sepsis, back injury, and diabetic foot complications), according to the study. One patient was unable to perform the program secondary to knee pain during cycling that dissipated shortly after stopping cycling. The investigators did not replace the patients that dropped out. This decreases the amount of data available to 75

77 analyze. This could mean that it may be harder to prove if the treatment is truly effective. 94. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Only the 18 patients that completed the 3 month training program were analyzed. None of the data from the 3 that dropped out was analyzed. Also, only 14 of the remaining 18 patients performed a post-training stress test and walk test. Due to the small amount of patients with these results the results of the stress test and walk test were not statistically analyzed. It is possible that the exclusion of the data of those patients that did not complete the program skewed the results to make it appear as though the treatment was more effective than it actually was. Are the valid results of this RCT important? Appraisal Criterion 95. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p- values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here 96. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? Reader s Comments Strength of Knee Extensors: 11.1+/- 4.5 vs /-8.9, p value= < Functional Outcome MOS SF-36: Mental Component: / vs. 55 +/- 7.8 p value= Physical Component: 36 +/- 8.7 vs /- 8.1, p value= Stress test & walk test not statistically analyzed secondary to the small number of patients who completed those tests. However, according to the study, 5 patients showed improvement in the aerobic fitness after training. Fourteen out of 18 patients completed the follow-up 6-min walk test. Nine of the 14 patients walked longer distances after training although statistical analysis was not applied due to the small number of subjects. Although the MOS SF-36 and the strength of knee extensors were statistically significant it doesn t provide overwhelming evidence this treatment is effective. The questionnaire is self-reported and therefore may not be an entirely accurate picture of increased physical performance. Also, knee extensor strength is important; however, I don t know if this is an accurate 76

78 representation of physical performance. The last two measures weren t statistically analyzed secondary to the small amount of subjects that completed them. Despite that, I feel as though these should have been analyzed. It is possible that the intervention is not effective and the investigators are trying to hide this by not analyzing the other measures. For the safety of my patient, I will take this information into account; however, not assume that the intervention was truly effective I will have to weigh the risks vs. the benefits. I don t believe this study alone will change the way I practice based off the results alone. 97. Do these findings exceed a minimally The MCID was not mentioned in this paper. important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 98. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 99. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 100. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 101. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? Reader s Comments This type of intervention could eventually be incorporated into the facility; however, a department for it would have to be created. So, this would not be easily implemented; however, it is possible. The description of the demographics was relatively vague. She is older than the average age. It did state some of the patients had diabetes, but it did not state how many. However, the screening process was pretty thorough though. Through this, I can see the patients involved were more medically stable than my patient. I m unsure I can use this intervention in spite of the differences. I don t think the potential benefits outweigh the potential risks for my specific patient. I think this intervention could possibly be appropriate for patients not so medically involved; however, I believe her complex medical history would make this intervention too risky to attempt. The intervention does fit within my patient s expectations and goals. She was very willing to participate in any physical therapy that would assist in allowing her to return home safely. 77

79 102. Are there any threats to external validity in this study? All of the patients came from the same clinic. So, it is possible this is a biased selection of patients and therefore these results cannot be applied to the general population. What is the bottom line? Appraisal Criterion Reader s Comments PEDRO score (see scoring at end of form) 2/10 Eligibility criteria was specified Summarize your findings and relate this back to clinical significance Although the two outcome measures that were analyzed showed that this intervention was statistically significant I m not sure those two measures (knee extensor strength and the MOS SF-36) are the best at predicting physical performance. In addition, secondary to the amount of bias that could possibly be introduced into the study I would want more definitive results from a better study design with a higher number of participants before I would call this clinically significant. 78

80 79

81 Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study please calculate the CER, EER, RBI/RRR, ABI/ ARR and NNT) + outcome - outcome a b + intervention c d - intervention CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) = Relative risk reduction (RRR) CER EER CER EER CER Absolute risk reduction (ARR) CER-EER Number needed to treat (NNT) 1/ARR Relative benefit increase (RBI) Absolute Benefit Increase (ABI) Number needed to treat (NNT) 80

82 CER EER EER CER CER EER-CER 1/ ABI Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

83 Name: Christi Hisaw Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Reboredo Mde M, Henrique DM, Faria Rde S, Chaoubah A, Bastos MG, de Paula RB. Exercise training during dialysis reduces blood pressure and increases physical functioning and quality of life. Artif Organs Jul;34(7): Level of Evidence (Oxford scale): 3B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. Reader s Comments The purpose was clearly stated. The investigators wanted to research the effects of an intradialytic aerobic exercise program on physical functioning, blood pressure, quality of life, and laboratory data. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study The paper discussed the fact that there is a high prevalence of hypertension in patients with end stage renal disease and that cardiovascular diseases are the primary cause of morbidity and mortality. They also discussed how these factors affect their quality of life and physical functioning. Due to these reasons, the researchers wanted to perform this study as a way to combat these issues. Does the research design have strong internal validity? Appraisal Criterion Reader s Comments 82

84 Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression All of the subjects were recruited from the same location, which could affect internal validity. Also, there was no control group to compare results although there was a control phase, as well as an intervention phase for the same group. There were only 14 of the 18 patients that completed the study; however the study did cite the reasons for the dropouts a kidney transplantation, excluded for coronary artery disease, non-adherence, and bone neoplasia. It is encouraging to know that the reasons were unrelated to the exercise program itself. Since lab values and blood pressure were measured, it is possible the equipment was not functioning properly. If this was the case, the results could have been skewed in either direction. The test was only 3 months long so it doesn t seem too long of a period for much maturation to take place considering the population. All of the patients were tested in the same manner. Since there was no control group, there could not have been compensatory equalization of treatments or compensatory rivalry. It doesn t appear that there was an issue with statistical regression. Are the results of this therapeutic trial valid? Appraisal Criterion 103. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 104. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the Reader s Comments There was no control group. So, it was impossible to randomly assign the subjects all patients received the experimental treatment. However, prior to the training program, they had a control phase in which they only performed stretching exercises. This served as the control. Despite having a control phase, this still made it impossible to randomly assign the patients and therefore could introduce bias into the study and skew the results making it appear as if there was an effect when there truly wasn t since the investigators and subjects have this knowledge. Yes, the investigators knew who was being assigned since there was only one group. As stated above, this could affect the results of the study secondary to 83

85 potential consequences of this knowledge for the study s results? 105. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 106. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 107. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 108. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 109. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 110. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 111. Were all patients analyzed in the groups to which they were randomized (i.e. was there allowing more bias to be introduced to the study. The study did report the demographics of the patients in a table, but there was no control group to compare to other than themselves during the control phase of the study. So, yes, they were quite similar since they were the same people. The subjects were aware they were receiving 2 different phases of treatment. However, it s unclear if they understood which phase was the experimental phase and which was the placebo. If they did know, it might affect the amount in which they participate in each phase of the study, thus introducing bias into the study and decreasing internal validity. The investigators were aware the group was receiving both a control phase and an intervention phase. It was impossible to blind them. This also decreases the internal validity of the study. Yes, all the patients were managed equally during both phases of the study. Each phase of the study lasted for 12 weeks. This should allow for enough time to observe physiological changes and increases in physical function in the patient should they occur. Although, I would have preferred if the intervention was administered for a longer period of time. Not all of the patients completed the study. Only 14 of the 18 enrolled completed the study. They did account for all the reasons the patients were unable to complete the study and it appeared as though the reasons had nothing to do with the experimental treatment. However, nothing was done about the attrition rate. With such a small amount of patients completing the study, it could be harder to prove the treatment had a positive effect on the patients. Not all of the patients were analyzed. The 4 patients that 84

86 an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? Appraisal Criterion 112. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p- values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here dropped out were not analyzed, but since there were only pre- and post-test results, there weren t any the researchers could carry forward to analyze. Reader s Comments Aerobic exercise: Mean time at beginning: /- 9.2 min Mean time at end: 33 +/-4.2 min P value: < 0.05 Physical functioning: Beginning of Control Phase: 6-Min Walk Test: /- 99.1m Borg Scale: /- 2.1 End of Control Phase: 6-Min Walk Test: /- 91.9m Borg Scale: /- 1.5 End of Intervention Phase: 6-Min Walk Test: / m Borg Scale: /- 1.1 P-value: < 0.05 Blood Pressure: Beginning of Control Phase: 12/14= hypertensive SBP: (awake) / mmhg (asleep) / mmhg DBP: (awake) / mmhg (asleep) / mmhg End of Control Phase: SBP: (awake) / mmhg (asleep) / mmhg 85

87 DBP: (awake) / mmhg (asleep) / mmhg After Intervention Phase: SBP (awake) / mmhg (asleep) / mmhg DBP (awake) /- 9.7 mmhg (asleep) / mmhg P-value= < 0.05 * Significant reduction of 12mmHg (SBP) and 5 mmhg (DBP) 24-hr blood pressure compared to the beginning of the control phase. Quality of Life: Physical Functioning: Beginning of Control Phase: / End of Control Phase: / End of Intervention Phase: / Social Functioning: Beginning of Control Phase: / End of Control Phase: / End of Intervention Phase: / Mental Health: Beginning of Control Phase: / End of Control Phase: / End of Intervention Phase: / P values= <

88 After control phase, 7/8 dimensions of SF-36 questionnaire showed non-significant increases. At end of intervention phase, physical functioning, social functioning, & mental health dimensions all had statistically significant increases compared to beginning of control phase. Laboratory Data: Hemoglobin (g/dl) Beginning of Control Phase: /- 1.7 End of Control Phase: /- 1.2 End of Intervention Phase: /- 0.8 Kt/V Beginning of Control Phase: 1.2 +/- 0.5 End of Control Phase: 1.5 +/- 0.2 End of Intervention Phase: 1.7 +/- 0.4 Creatinine (mg/dl) Beginning of Control Phase: /- 2.5 End of Control Phase: /- 1.7 End of Intervention Phase: /- 1.9 LDL (mg/dl) Beginning of Control Phase:86.2 +/ End of Control Phase: / End of Intervention Phase: / Triglyceride (mg/dl) Beginning of Control Phase: /

89 End of Control Phase: / End of Intervention Phase: / P values= < What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? According to the statistical findings of the study, it is possible to have positive effects on multiple factors of health by performing intradialytic exercise. Factors of quality of life, physical function, time able to perform aerobic exercise, blood pressure, and laboratory values can all be positively impacted. Looking at these values alone, may mean that there are multiple reasons to have my patients perform this type of exercise. If I find this treatment to be safe and effective, I could explain to my patients the possible potential effects it could have on multiple factors of their health. However, I would want to look at other factors in this paper, as well as other studies Do these findings exceed a minimally The MCID was not mentioned in this paper. important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 115. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 116. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 117. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? Reader s Comments This intervention sounds like it could be implemented into the facility s practice; however, it would take time and money to set it up. More quality studies would need to be done before I could present this to the department to try to get a program set up for patients. Currently, we wouldn t have the 3 rd party coverage. The mean age was quite a bit younger than my patient. In addition, only 1 of the 14 patients had diabetes mellitus. Considering the complex medical history of my patient, I don t believe the risks would outweigh the benefits for her. The more research I perform, the more I m discovering that this type of program should be 88

90 implemented very early on when patients are first put on dialysis before their medical histories become too complex Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 119. Are there any threats to external validity in this study? My patient would have been willing to perform this exercise training program were she able. She very much wanted to return home and was willing to do what she had to do in order to get there. All of the patients came from the same clinic. So, it is possible this is a biased selection of patients and therefore these results cannot be applied to the general population. What is the bottom line? Appraisal Criterion Reader s Comments PEDRO score (see scoring at end of form) 2/10 Eligibility criteria was specified. Summarize your findings and relate this back to clinical significance This study shows that by performing intradialytic exercise it may be possible to improve multiple health factors. However, given the amount of participants that did not complete the study and the already small sample population these results need to be taken with caution. In addition, a significant amount of bias has the possibility of being introduced into the study, whether intentional or unintentional. Taking all of the factors into account, I would say that this paper does not have a lot of clinical significance. I would want higher quality studies to supplement this study before I implemented this treatment into my practice. 89

91 90

92 Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study please calculate the CER, EER, RBI/RRR, ABI/ ARR and NNT) + outcome - outcome a b + intervention c d - intervention CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) = Relative risk reduction (RRR) CER EER CER EER CER Absolute risk reduction (ARR) CER-EER Number needed to treat (NNT) 1/ARR Relative benefit increase (RBI) Absolute Benefit Increase (ABI) Number needed to treat (NNT) 91

93 CER EER EER CER CER EER-CER 1/ ABI Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

94 Name: Christi Hisaw Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Ribeiro R, Coutinho GL, Luras A, Barbosa AM, Camargo de Souza JA, Diniz DP, Schor N. Effect of resistance exercise intradialytic in renal patients chronic in hemodialysis. J Bras Nefrol. 2013;35(1):13-9. Level of Evidence (Oxford scale): 3B Is the purpose and background information sufficient? Appraisal Criterion Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. Reader s Comments The purpose was clearly stated the purpose of the study was to study the effects of resistance exercise in the treatment and quality of life in patients receiving hemodialysis by looking at laboratory assessments, muscle strength testing (FM), and quality of life questionnaire (SF-36). A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study The study discusses that people with chronic kidney disease have limited functional capacity that leads to other health complications, thus affecting quality of life. The investigators state that research shows that resistance exercise could help decrease these complications, as well as improve urea removal during hemodialysis and increase the sensitivity of insulin receptors and the number of insulin-dependent glucose transporters. Diabetes mellitus is the leading cause of chronic kidney disease requiring renal replacement therapy. Effects of resistance exercise has not been reported in those with both diabetes mellitus and chronic kidney disease so the investigators felt it was important to assess the effects of resistance exercise on the quality of life in this population. 93

95 Does the research design have strong internal validity? Appraisal Criterion Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Reader s Comments The sample population was all volunteers that were recruited from the same Institute. The study did not state whether or not patients dropped out of the study; however, they did state they only made the study 8 weeks long in order to avoid a high attrition rate since patients with both chronic kidney disease and diabetes mellitus have a high degree of limitations that could potentially cause a high drop-out rate. The instruments used to measure the results were not discussed. This could cause a threat to internal validity secondary to possible inappropriate choice in measurement tool or the tool could have not been calibrated correctly. The study did not go on long enough to have maturation affect the results. It was unclear if the patients or the investigators were blinded. This could also have an effect on internal validity as will be discussed in later questions. It is unclear if statistical regression could have skewed the results. Are the results of this therapeutic trial valid? Appraisal Criterion 120. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 121. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 122. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? Reader s Comments The paper does not state if the subjects were randomly assigned to the 4 groups studied. This could potentially affect the results if they were not randomized because the researchers could potentially assign the patients they think would have positive results into the experimental group causing skewed results. It was not stated if the investigators knew who was being assigned to which group prior to allocation. If they were not blinded, this could introduce bias into the study and skew the results potentially showing positive results when there truly weren t significant results. Some demographics about the groups were reported; however, they were relatively vague and did not discuss if the groups were similar at the start of the trial. All that 94

96 a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 123. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 124. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 125. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 126. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 127. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled was discussed was the mean age, amount of men & women, family income, time in school, the amount of patients that were retired, length of time on dialysis, and the amount of patients with Type II diabetes mellitus. This was discussed for all 60 patients involved, but it was not broken down by each individual group. This allows for a huge amount of bias to be introduced because there is no way of knowing how similar they truly are. The investigators could be comparing apples and oranges and the reader would have no way of knowing. This could allow for skewed results so I would be very cautious about putting too much stock into these results. The study was not specific about if the subjects were blinded. If they did not mention it, then it s safe to say they most likely were not blinded. If this is the case, bias could be introduced because it could affect the amount of effort the subjects put into participating and could potentially skew the results making it appear as if there were positive results when there truly were not. If the study did not mention if the investigators were blinded, then it is safe to say that most likely they were not blinded. This could introduce bias into the study because the way they interpret the results could be skewed (intentionally or unintentionally). As far as the study describes, it appears as though the groups were managed equally, apart from the actual experimental treatment. The study could have been longer. Eight weeks would keep patients from dropping out because it is such a short amount of time to participate. However, I m not sure this is an adequate amount of time to show the physiological changes that would need to occur in order to increase quality of life and physical performance in patients. The study did not discuss whether all of the patients completed the study; except to say that they kept the amount of time for the study short in order to avoid dropouts. To the best of my knowledge, all of the subjects completed the study. If they did not complete the study, then the results could possibly be skewed 95

97 with respect to the study s findings? 128. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? Appraisal Criterion 129. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p- values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here leading the reader to believe the treatment had a positive effect when it, indeed, did not. To my knowledge, all of the patients that participated in the study were analyzed in the groups to which they were assigned; however the study was not completely clear about this information. If data were to be excluded, it is possible that the study showed results that were not in fact accurate. Reader s Comments Group with DM + CKD + Resistance Exercise Serum Creatinine (Mg/dL) Initial /- 0.1 Final 9.4 +/- 0.2 P value= < Predialysis Urea Initial /- 0.9 Final /- 1.2 P value= < Postdialysis Urea Initial /- 0.9 Final /- 1.5 P value= < Glycemia (Mg/dL) Initial /

98 Final /- 4.6 P value= < Muscle strength (In degrees) Initial 2.3 +/- 0.5 Final 3.5 +/- 0.6 P value= < Quality of Life Initial Final FC / /-4.50 PA / / PP / / GH / /-6.43 VIT / / SF / / ES / / MH / / *FC=functional capacity, PA=physical appearance, PP= pain perception, GH= general health, VIT= vitality, SF= social function, ES= emotional state, MH= mental health 130. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? For Group 1 (CKD + DM2, performing the RE program): all outcome measures were considered statistically significant. The increased creatinine and muscle strength tests may indicate that my patient could develop both increased muscle mass and strength. In addition, the glucose levels could be better controlled since, according to the study the glucose levels significantly decreased just not enough to modify drug therapy. All aspects of the 97

99 quality of life questionnaire also improved according to the study. All of these findings suggest that my patient s life could potentially improve both physically and mentally and a number of health factors could improve. Based on the statistics alone, this could potentially mean that I have found a new intervention to introduce to my patient. However, more than just the statistics need to be evaluated before I implement this into my practice Do these findings exceed a minimally The MCID was not brought up or discussed. important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion 132. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 133. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 134. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 135. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? Reader s Comments The intervention could possibly be appropriate for some patients, but I don t believe that the treatment would be appropriate for my particular patient this question was created for. I don t believe these patients were similar to mine because although they also have type II diabetes, my patient had more severe medical issues and was not as stable as the ones participating in this study. I don t think I could use the intervention given the differences. No, the potential benefits do not outweigh the potential risks using this intervention with my patient. My patient s complex medical history made her inappropriate for this intervention. The intervention does fit within my client s goals; however, I don t think it s an appropriate treatment for her Are there any threats to external validity in this study? All of the subjects came from the same clinic. So, this could introduce some threats to external validity; however, no external events occurred to my knowledge that would affect it. 98

100 What is the bottom line? Appraisal Criterion Reader s Comments PEDRO score (see scoring at end of form) 2/10 Eligibility criteria was specified. Summarize your findings and relate this back to clinical significance This study had the potential to be of good quality. However, there were many questions that the study did not address. So, it has to be assumed that the participants were not blinded or randomized, investigators were not blinded, and attrition rate is unknown. Secondary to this, despite the fact there were numerous positive results, the results have to be taken with caution. In addition, these findings can only be applied to those with diabetes mellitus and chronic kidney disease not those with more complicated medical issues. Although there were numerous outcome measures found to be statistically significant, I would like to see a higher quality study with a larger sample population before calling this study clinically significant. 99

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102 Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study please calculate the CER, EER, RBI/RRR, ABI/ ARR and NNT) + outcome - outcome a b + intervention c d - intervention CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) = Relative risk reduction (RRR) CER EER CER EER CER Absolute risk reduction (ARR) CER-EER Number needed to treat (NNT) 1/ARR Relative benefit increase (RBI) Absolute Benefit Increase (ABI) Number needed to treat (NNT) 101

103 CER EER EER CER CER EER-CER 1/ ABI Pedro Scoring System: Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

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