CRITICALLY APPRAISED PAPER (CAP)

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1 FOCUSED QUESTION CRITICALLY APPRAISED PAPER (CAP) Will adults diagnosed with rheumatoid arthritis who participate in an intensive hand exercise program improve in areas of hand strength, joint mobility, hand pain, and functional ability compared to participants in a conservative exercise program? Ronningen, A., & Kjeken, I. (2008). Effect of an intensive hand exercise programme in patients with rheumatoid arthritis. Scandinavian Journal of Occupational Therapy, 15, CLINICAL BOTTOM LINE: Occupational therapy (OT) practitioners can play a vital role in the treatment and management of rheumatoid arthritis (RA). RA is the most common inflammatory rheumatic disease, and people diagnosed report hand function to be a primary concern. Hand pain, along with decreased strength and range of motion, affect individuals with arthritis daily, particularly affecting their ability to engage in meaningful activities. One way occupational therapists can address these issues is by developing and implementing an appropriate hand exercise program to positively affect functional ability. The findings from this study indicate that an intensive hand exercise program (IEP), which is a program conducted a minimum of 5 days per week with increased repetitions of hand exercises, is more effective in improving hand strength than a conservative exercise program (CEP). However, it is important for OT practitioners to remain client-centered and individualize hand exercise programs according to the patient. Occupational therapists should remain cautious when implementing a more strenuous exercise routine among clients with RA. Conservative and less repetitious exercise programs may be more appropriate for clients whose goal is to increase joint mobility and maintain strength, whereas a more intensive exercise program will aim to increase overall hand strength. RESEARCH OBJECTIVE(S) List study objectives. Determine whether an intensive hand exercise program would improve results in increasing hand strength, joint mobility, and overall functional abilities while decreasing pain in patients diagnosed with rheumatoid arthritis when compared to a conservative hand exercise program. 1

2 DESIGN TYPE AND LEVEL OF EVIDENCE: Level II: 2-group clinical controlled trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. The sample selection for this study was patients recruited from a 32-bed inpatient facility for rheumatoid diseases at the Lillehammer Hospital in Norway. Up to 2 days post admission date, informed consent was received from all participants for study involvement. The first 30 participants to be admitted were consecutively placed into the CEP group, while the next 30 participants were placed into the IEP group. To gather results considered clinically relevant (significance level of 0.05), the authors calculated that a sample size of 30 participants was required for each treatment group. Of the initial 60 recruited participants, 50 completed the study. Of the 50 total participants, 43 were women (86%) and 7 were men (14%). Inclusion Criteria Participants included in this study were diagnosed with rheumatoid arthritis according to the classification criteria of the American College of Rheumatology, had a disease duration of more than 1 year, were between 18 and 70 years of age, and had communication fluency in the Norwegian language. Exclusion Criteria Participants excluded from this study were those experiencing functional problems resulting from diseases other than RA, pregnancy, hand surgery in the 6 months before the study began, any mental or cognitive deficits, or attended five or fewer training sessions during their initial hospital stay. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 50; 24 in the CEP group and 26 in the IEP group #/ (%) Male 7/50 (14%) #/ (%) Female 43/50 (86%) Ethnicity N/R Disease/disability diagnosis Participants had a diagnosis of rheumatoid arthritis over a 1-year duration and were between the ages of 18 and 70 years old. INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: CEP 2

3 Brief description of the intervention After being placed into the CEP, participants were assessed at the time of admission, at discharge from the hospital (approximately 2 weeks after admission), and at 12 weeks after discharge. This program consisted of a regime of conservative and gentle exercises focusing on increasing joint mobility and maintaining hand strength. Eleven exercises were each completed three times during the program. Examples of exercises include: performing resistance against soft dough, such as flexing the fingers into a fist; rolling a ball of dough with the palm on the table with extended fingers; and flexing and extending the interphalangeal joints of the fingers. How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Group 2: IEP Brief description of the intervention How many participants in the group? The first 30 participants to be admitted into the hospital were placed into the study; however, after dropouts, final CEP number of participants was 24. Initial sessions took place within the hospital; after discharge, participants were given a leaflet with descriptions and pictures of the exercises and were encouraged to continue with their usual exercise routines within their homes. All group sessions were led by an occupational therapist. During the 2-week inpatient hospital stay, occupational therapy sessions were held daily. N/R The focus of the IEP group was to increase joint mobility and hand strength simultaneously. The largest difference between this program and the CEP was the increase in number of repetitions, especially for finger flexion and extension. In addition to the exercises performed within the CEP, the IEP focused on opposition of the thumb against resistance. Each exercise was completed 10 times with the exception of the radial finger walking, which was completed five times. The section of exercises involving finger flexion and extension were repeated three times throughout each therapy session. Exercises involving opposition of each fingertip with the thumb and rolling a ball using the palm were removed due to their lack of influence on grip force. The next 30 participants to be admitted into the hospital after the CEP group was created were placed into the IEP group; however, after dropouts, the final number of participants was 26. 3

4 Where did the intervention take place? Who delivered? How often? For how long? Initial sessions took place within the hospital. After discharge, participants were given a leaflet with descriptions and pictures of the exercises and were encouraged to continue their exercise regime within their homes. All group sessions were led by an occupational therapist. During the 2-week inpatient hospital stay, occupational therapy sessions were held daily. After discharge, participants in the IEP group were encouraged to exercise once a day at least 5 times a week prior to their next assessment period. N/R Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: Co-intervention: Timing: Site: YES The study was completed at a small 32-bed inpatient hospital unit, and there was a high potential for carryover of information between participants of each group. Also, the patients completed the IEP at home after discharge. Use of different therapists to provide intervention: YES A total of four occupational therapists carried out various interventions across both groups; however, for each patient, the same OT conducted all the assessments. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: 4

5 Measure 1: Measure 2: Grippit electronic instrument This primary outcome measure was used to test grip and three-pod pinch strength. Measurements were taken at the time of the admission, at discharge or Grip Ability Test (GAT) This secondary outcome measure assessed the individual s ability to grip three standardized objects. The participant was asked to don a Flexigrip stocking over the non-dominant hand, place a paper clip on an envelope, and pour water from a jug. The GAT was conducted at the time of the admission, at discharge or Measure 3: Modified version of Stanford Health Assessment Questionnaire (MHAQ) This evaluation tool measures physical function in activities of daily living in individuals with arthritis. Activities included in this outcome measure include getting dressed, transferring in and out of a bed and car, lifting a full glass to the mouth, walking outdoors on flat ground, picking up clothing from the floor, and turning taps on and off. The assessment was given at the time of the admission, at discharge or Measure 4: 5

6 Measure 5: Measure 6: Measure 7: Joint mobility Joint mobility was measured in millimeters. Measurements were taken for finger flexion, extension, and opposition, as well as wrist flexion and extension. A goniometer was utilized for wrist range of motion. Measurements were taken at the time of the admission, at discharge or Hand pain This scale was used to measure the amount of hand pain experienced during the grip and pinch strength test. Hand pain was assessed at the time of the admission, at discharge or Self-Estimated Hand Function (SEHF) This self-reported visual analogue scale (VAS) was used to measure selfperceptions of hand function. This scale was given at the time of the admission, at discharge or Interview 6

7 The interviews were conducted to gain more insight into the experience of patients allotted to the IEP group. The interview also allowed the researchers to gain insight as to how the participants managed exercising within their homes. The interview was given 12 weeks after discharge. Six participants agreed to the interview, all of which were participating in the IEP. Measure 8: Disease variables The patients level of pain, fatigue, and disease activity were assessed using a VAS. This scale was given at the time of the admission, at discharge or Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. The evaluators were not blind to treatment status. Due to the research taking place at a rheumatology hospital, the evaluators were not blinded to group allocation or treatment; however, each participant was assessed by the same occupational therapist throughout the study. Recall or memory bias. Check yes, no, or NR, and if yes, explain. YES Others (list and explain): There was a possibility for the participants to experience recall or memory bias because of the self-reported outcome measures for pain and hand function. Due to the lack of multiple assessors, there is minimal interrater reliability, which decreased the trustworthiness and reliability of the research conducted. RESULTS List key findings based on study objectives 7

8 Include statistical significance where appropriate (p < 0.05) Include effect size if reported 1. The average level of pain, fatigue, and disease activity for both the control and intervention group was moderate at baseline, and both improved slightly and with statistical significance over the first 2 weeks of the program. Disease variability for both groups did not change significantly from baseline assessment to the assessments held at 14 weeks, although there was a significant decrease in fatigue present in the IEP group (p = 0.01). 2. For hand strength, there was a significant difference in dominant hand strength after 2 and 14 weeks for participants in the IEP group. At 2 weeks, there were significant differences in average pinch and grip strength for both hands (p = 0.01 for dominant hand and p = 0.05 for non-dominant hand). At 14 weeks, the IEP group continued to show significant results, increasing non-dominant hand grip strength compared to the CEP (p = 0.04). 3. After 2- and 14-week assessments, hand pain had decreased significantly in nondominant hands of those in the IEP group on half of the VAS pain measures taken after grip and pinch strength measurement. 4. Significant improvements were seen in joint mobility of the dominant hands in all but one participant in the IEP group, with few differences seen regarding mobility between the IEP group when compared to the CEP group. 5. Assessing bilateral measures of function, both IEP and CEP groups experienced significant improvements at 2 weeks when compared to the CEP group, with significant changes present in the MHAQ and GAT scores after 14 weeks for the IEP group. However, differences were not significant between the two groups at 2 and 14 weeks except in GAT scores for the IEP group. 6. The interviews conducted with six participants revealed that overall, individuals were content with the exercise programs and felt that learning to exercise is very important. Participants voiced that it was challenging at times to schedule exercise into their daily routines. Four of the six interviewed participants reported that the IEP program had increased joint flexibility. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. The researchers calculated that a sample of 60 participants was needed to detect a significant difference. However, only 50 participants finished the study, so the study was not adequately powered. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. YES Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. 8

9 YES Was the percent/number of subjects/participants who dropped out of the study reported? YES Limitations: What are the overall study limitations? The aim of the study was to compare and contrast the effectiveness of two hand exercise programs for individuals diagnosed with RA. A limitation of this experiment was a lack of a randomized controlled trial. Also, the evaluators were not blinded in this study, which may have affected the outcome measurements of the participants. Self-reported measures also were used, and participants vary considerably in how they perceive and rate pain and hand function. Lastly, half of the items of the MHAQ related more toward spine and lower extremity function; studies in the future should aim to use hand-related function assessments CONCLUSIONS State the authors conclusions related to the research objectives. Rønningen and Kjeken s (2008) research demonstrated that an intensive hand exercise program can improve hand strength in individuals diagnosed with RA more than a conservative exercise program. Not only did participants receiving the intensive exercise program show improved hand strength, but they also experienced significant decreases in hand pain. Grip ability test scores of the intensive exercise program participants also were significantly different, showing improved handgrip abilities. However, this research does not provide evidence that an intensive exercise program improves functional ability. Ultimately, the intensive exercise program was well tolerated by individuals with RA, but future studies should explore different exercise methods and individualized programs that fit the client s needs. Future research using randomized controlled trials and more sensitive measures of hand function are recommended. This work is based on the evidence-based literature review completed by Alexis Nims, MOTS; Kayli Schumacher, MOTS; and Jan Stube, PhD, OTR/L, Faculty Advisor, University of North Dakota. CAP Worksheet adapted from Critical Review Form--Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: 9