TOTAL HIP REPLACEMENT is one of the most effective

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1 1652 ORIGINAL ARTICLE Effect of Multiple Physiotherapy Sessions on Functional Outcomes in the Initial Postoperative Period After Primary Total Hip Replacement: A Randomized Controlled Trial Kellie A. Stockton, BAppSc Physio, Grad Dip Physio, Kerrie A. Mengersen, PhD ABSTRACT. Stockton KA, Mengersen KA. Effect of multiple physiotherapy sessions on functional outcomes in the initial postoperative period after primary total hip replacement: a randomized controlled trial. Arch Phys Med Rehabil 2009;90: Objective: To determine whether increasing physiotherapy input from once to twice per day will result in earlier achievement of functional milestones (ie, independence in mobility and transfers) and decreased length of stay (LOS) in patients undergoing a primary total hip replacement. Design: Randomized controlled trial. Setting: Metropolitan private hospital. Participants: Patients (N 57) with primary total hip replacement were randomly assigned to the twice daily (treatment, n 30) and once daily (control, n 27) groups. Patients who chose to attend hydrotherapy were excluded from the randomization process; however, they gave consent for outcome measures to be collected for comparison with the randomized groups. Interventions: The control group received usual care, and the treatment group received twice-daily physiotherapy from day 1 after surgery to discharge. Main Outcome Measures: The Iowa Level of Assistance at postoperative days 3 and 6 and LOS. Results: This study demonstrates that patients who received twice-daily land-based physiotherapy after primary total hip replacement attained earlier achievement of functional milestones than patients that received once-daily physiotherapy. A statistically significant (P.041) but not clinically significant difference was evident in the Iowa Level of Assistance score at day 3. There was no difference between the groups in Iowa Level of Assistance measures on day 6 or on LOS. Conclusions: Patients who received twice-daily physiotherapy showed a trend toward earlier achievement of functional milestones; however, this finding did not translate to decreased LOS. Key Words: Arthroplasty; Exercise; Hip; Rehabilitation by the American Congress of Rehabilitation Medicine From the Physiotherapy Department, Wesley Hospital (Stockton); Arthritis Queensland (Stockton); and School of Mathematical Sciences, Queensland University of Technology (Mengersen), Brisbane, Queensland, Australia. Supported by the Wesley Research Institute (grant no. 2006/14) and ARC Linkage Project (grant no. LP ). No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. Reprint requests to Kellie A. Stockton, BAppSc Physio, Grad Dip Physio, Arthritis Queensland, PO Box 2121, Windsor, Queensland 4030, Australia, k.stockton@uq.edu.au /09/ $36.00/0 doi: /j.apmr TOTAL HIP REPLACEMENT is one of the most effective treatment modalities for arthritis. 1 In 2005 and 2006, a total of 21,050 primary THR were performed in Australia, an increase of 1.8% on the previous year. 2 Postoperative stays for patients undergoing THR has significantly reduced in recent times. Many centers aim for discharge at day 5 to 7. 3 Early postoperative rehabilitation after THR focuses on restoring mobility, strength, and flexibility; reducing pain; preventing complications such as deep-vein thrombosis; teaching adherence to range of motion and weight-bearing precautions; ordering appropriate equipment; patient and family education; and aligning home resources. 4 The primary goals of physiotherapy after THR are unassisted transfers and ambulation with appropriate devices on level surfaces and stairs. 5 A limited number of studies have demonstrated that increased physiotherapy in the initial postoperative period after THR leads to earlier achievement of functional milestones 6 and reduced LOS. 6-8 However, the studies mentioned either failed to use a reliable, validated functional outcome measure 6 or used measures that could only be applied to patients that were fully weight bearing or in the rehabilitation setting. 8 The setting for this study was a large private hospital in a major metropolitan center with 60 inpatient orthopedic beds. Approximately 200 primary THR procedures were performed at the center in The purpose of this study was to investigate the effect of twice-daily physiotherapy on achieving functional milestones, thus facilitating discharge from the hospital. METHODS Approval for the study was obtained from the hospital ethics committee. Patients admitted for elective primary THR who gave written informed consent were eligible for inclusion in this prospective study. Exclusion criteria were unwillingness to participate, inability to perform the assessment procedures, and an inability to mobilize preoperatively as a result of musculoskeletal or neurologic problems. Patients who chose to attend hydrotherapy were excluded from the randomization process, however, they gave consent for outcome measures to be collected for comparison with the randomized groups. From November 2006 to May 2007, a total of 57 patients were randomly allocated by a concealed allocation procedure to 1 of 2 groups. Patients in the control group (group A) received once-daily physiotherapy, which included mobilization, exercises, and transfer practice. The exercises were initially performed in the supine position and included ankle dorsiflexion and plantar flexion, static quadriceps and innerrange quadriceps, gluteal contractions, hip and knee flexion, LOS THR List of Abbreviations length of stay total hip replacement

2 PHYSIOTHERAPY AFTER TOTAL HIP REPLACEMENT, Stockton 1653 and hip abduction. Previous authors have found that the addition of bed exercises to a mobility program after THR did not affect functional outcome. 9,10 However, in this study, the bed exercises were not a major emphasis of the study and were primarily used as a component of deep-vein thrombosis prophylaxis and assisting with bed mobility. Patients were taught the exercises and reminded to do them 4 times a day until the patient was independently mobile. Practice of bed mobility and transfers were a focus until independence was achieved. Patients were progressively mobilized by using an appropriate aid and level of assistance ensuring an optimal gait pattern at each stage. This was further enhanced by the addition of standing exercises and gait reeducation. Standing exercises included toe raises, quarter squats, hip flexion, abduction, and extension on the operated leg. Final preparation for discharge included patient education regarding precautions after a THR and the safe use of stairs. The second treatment group (group B) underwent an identical exercise protocol to group A. In addition, patients in group B received an additional physiotherapy treatment each day concentrating on achieving functional milestones that is, bed transfers and mobility. All physiotherapists who treated patients participating in the study were thoroughly instructed in the treatment protocols for the 2 groups to ensure that interventions were as standardized as possible. A mobilization record was maintained for all patients to monitor mobilization performed in addition to actual physiotherapy treatments. Twenty-one people declined to be part of the randomization process because they preferred to attend hydrotherapy (group H). These patients received 1 land-based physiotherapy session only from days 1 to 3 (identical to the protocol for group A once-daily physiotherapy). From day 4 onward, this group received once-daily land-based physiotherapy and 1 hydrotherapy session daily (a total of 2 treatments per day until discharge). The hydrotherapy session consisted of exercises similar to the land-based program focusing on gait education and standing exercises. Each patient s age, sex, diagnosis, attendance at preadmission clinic, preoperative mobility, preoperative Oxford Hip score, operative procedure, and postoperative complications were recorded. The Oxford Hip score 11,12 is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient s perspective. It comprises 12 questions designed to be answered by the patient and has been shown in the literature to produce data of high validity and reliability. 13 Functional status was assessed on days 3 and 6 postoperatively by using the Iowa Level of Assistance Scale described by Shields et al. 14 This scale measures functional outcomes including moving from lying to sitting and from sitting to standing, mobilizing 4.57m, climbing up and down 3 stairs, and measuring gait speed over a distance of 13.4m. Each outcome is graded by using an ordinal scale according to the level of assistance and gait aid required. An overall score is obtained with a range from 0 (no assistive device and completely independent) to 50 (using a frame but unable to attempt test for safety reasons). A clinically significant difference in scores is (See appendix 1 for details.) The timing of the initial Iowa Level of Assistance outcome measurement (day 3) was chosen because it was most likely that this was the earliest time that patients could complete all 5 functional tasks. The second measurement time of day 6 was chosen because sufficient time had elapsed from the initial measurement time for measures to improve, but discharge from the hospital had not yet occurred. Initially the Iowa Level of Assistance was also recorded preoperatively, but was abandoned after the first 12 patients recorded 0 on the scale because no clinical significance was observed. Power calculations indicated that a sample size of 22 patients in each group was sufficient to detect a clinically significant difference of 7.0 on the Iowa Level of Assistance Scale, 9,10 with a power of.90 and a significance level of.05. Because nonparametric tests were planned, the sample size was increased by 20% to a minimum of 26 patients in each group. Statistical Analysis The data set was analyzed by SPSS software, version 14. a In the first exploratory stage, data were graphed and summary statistics were calculated for all outcomes. Where appropriate, nonparametric tests were used. The Kruskall-Wallis test was used to evaluate the ordinal data from the Iowa Level of Assistance scale. An independent t test was used to compare LOS. Oxford Hip score, age, group, day 3 Iowa Level of Assistance, and day 6 Iowa Level of Assistance were entered into a regression analysis with the backward conditional method, with LOS as the dependent variable. Intention-to-treat analysis was used, and a significance level of.05 was used. RESULTS Eighty patients were approached to enter the study (fig 1). Two patients declined to participate. Twenty-one patients consented to having outcome measures recorded but declined randomization because they wished to attend hydrotherapy. Ten patients (5 in group A, 4 in group B, 1 in group H) were ready for discharge home before day 6; thus, day 6 Iowa Level of Assistance was not recorded for these patients. All other outcome measures for these patients (demographic data, day 3 Iowa Level of Assistance, LOS, and independence into bed) were recorded. Baseline Measures A summary of the demographic data of the patients included in the study is displayed in table 1. The primary reason for undergoing a THR was osteoarthritis (93%). There were no statistically significant differences at baseline between the groups. Length of Stay There was no statistically significant difference between the groups with respect to LOS (group A d, group B 8 3.3d; t ; P.851). Iowa Level of Assistance The Iowa Level of Assistance score demonstrated statistically significant improvement over time (P.001) across groups. Day 3 Iowa Level of Assistance scores showed a statistically significant difference between groups (P.041). However, the result was not clinically significant. There was no statistically or clinically significant difference between the groups with respect to day 6 Iowa Level of Assistance (P.129). Discharge Destination Two patients from each group were transferred to a rehabilitation center. All other patients were discharged directly home (93% of participants in the trial). Regression Analysis Oxford Hip score, age, group, day 3 Iowa Level of Assistance, and day 6 Iowa Level of Assistance were entered into a regression analysis by the backward conditional method, with LOS as the dependent variable. The overall model was significant at the P less than.001 level. The model predicted 50% correctly. Oxford Hip score and group were excluded in step 2, and it was shown that

3 1654 PHYSIOTHERAPY AFTER TOTAL HIP REPLACEMENT, Stockton Declined to participate Eligible patients n=80 n=2 Control group Once-daily physiotherapy n=27 Intervention group Twice-daily physiotherapy n=30 Elected to attend hydrotherapy n=21 Day 3 n=27 Day 6 n=22 Follow up Day 3 n=30 Day 6 n=26 Follow up Day 3 n=21 Day 6 n=20 Follow up Withdrawn n=0 Withdrawn n=0 Withdrawn n=0 Analyzed n=27 Analyzed n=30 Descriptive report n=21 Fig 1. Flow chart of participants in trial.

4 PHYSIOTHERAPY AFTER TOTAL HIP REPLACEMENT, Stockton 1655 Table 1: Demographic Data Demographics Group A Group B Hydrotherapy Group Patients (n) Age (mean SD) M:F ratio 13:14 17:13 10:11 Diagnosis (n) OA 26 AN 2 OA 28 DD 2 OA 19 AN 1 DD 1 Fixation (n) Hybrid Cemented Cementless Oxford Hip score (mean SD) Abbreviations: AN, avascular necrosis; DD, developmental dysplasia; OA, osteoarthritis; F, female; M, male. age and Iowa Level of Assistance at day 6 were independent predictors of LOS (P.022 and P.001, respectively). Day 3 Iowa Level of Assistance, although contributing to the model, was not a statistically significant predictor of LOS. Hydrotherapy The hydrotherapy group was not included in the statistical analysis; however, data are presented for observational purposes only. As shown in table 2, there is little difference between the means of group A and B with respect to day 6 Iowa Level of Assistance and LOS. Day 3 Iowa Level of Assistance ( ) was very similar to group A ( ). Mobilization Record and Compliance With Bed Exercises A detailed mobilization record was kept for each patient to monitor any additional walks that the patient had (other than during physiotherapy treatments). There was no difference between the groups. Before the patient was safe and independent in mobility (with appropriate gait aid), the only additional mobilization that any patient received (regardless of group) was to the shower or toilet. Completion of bed exercises was documented on the clinical pathway. All patients in the study reported performing the exercises at least 4 times a day. DISCUSSION The patients enrolled onto this study were homogenous, with no statistically significant difference in baseline data measures between groups. The age and presenting pathology of patients in this study are very similar to Australian National Joint registry figures (mean age for primary THR, 67y; 88.7% osteoarthritis). 2 Oxford Hip scores were lower (ie, less disability) than measured in other studies. 13 This is indicative of private patients compared with public patients. Patients who undergo THR in the public system often have lengthy waiting times before surgery and thus have higher Oxford Hip scores as a result of deteriorating arthritis demonstrating worse pain/disability. 3 It is important to evaluate outcomes in the private hospital setting in Australia because more than half of primary THRs performed in Australia are in this setting. 2 There was no statistically significant difference between the groups with respect to LOS. In the private hospital setting in Australia, many patients expect to stay a minimum of 7 days, which is often a barrier to earlier discharge. Discharge venue also affects LOS. Patients discharged to a rehabilitation center can usually leave the acute care ward earlier than patients discharged directly home. Ninety-three percent of patients involved in this study were discharged directly home. The regression analysis demonstrated that age was a statistically significant factor affecting LOS. Several studies have demonstrated that older patients take longer to achieve functional milestones. 4,5 Munin et al 8 investigated 86 patients undergoing hip or knee arthroplasty and found that early inpatient rehabilitation decreased LOS in elderly patients undergoing total knee arthroplasty. This study, however, was carried out over 10 years ago and evaluated the difference between commencing rehabilitation on postoperative day 3 or day 7 rather than in the initial postoperative period. This commonly observed effect of age highlights the need for further research evaluating the effect of multiple daily physiotherapy sessions on LOS in younger patients undergoing THR. The Iowa Level of Assistance results are higher in this study compared with other similar studies. 9,10 Patients who were non weight bearing or partial weight bearing were included in this study, whereas they were excluded in other studies. Weight bearing affects gait aid utilization, thus resulting in a higher Iowa Level of Assistance. In addition the Iowa Level of Assistance is unable to evaluate differences in the quality of gait pattern. One study that used the Iowa Level of Assistance after THR found that some patients were able to mobilize without a gait aid but still had a positive Trendelenburg test, poor capacity to bear weight, and an inability to walk more than 15m. 10 Physiotherapists at our center tend to prescribe gait aids for longer periods of time than other centers to facilitate good gait quality. There was a statistically significant, but not clinically significant, difference in the Iowa Level of Assistance between groups at day 3. However, there was no statistically or clinically significant difference in Iowa Level of Assistance between groups at day 6. This finding is supported by the results from the hydrotherapy group. Group H received once-daily physiotherapy on days 1 to 3, thus receiving the same physiotherapy protocol as group A until day 3. Thus, it would be assumed that day 3 Iowa Level of Assistance would be similar in groups A and H, which was indeed observed. Peerbhoy et al 6 studied 229 patients undergoing elective THR or total knee arthroplasty (n 163) to examine trends in achieving functional milestones. The results indicated that patients that achieved functional milestones earlier had a reduced LOS. In addition, the hospitals where the study was carried out did not provide weekend physiotherapy, and it was observed that patients that were operated on later in the week were slower to achieve functional milestones ( d slower than those patients that received immediate postoperative physiotherapy). The lack of physiotherapy in the crucial initial postoperative period may have contributed to this. A feature of this study is that one of the outcomes used was distance walked (5, Table 2: Results: LOS and Iowa Level of Assistance Scores Outcome Measure Group A (once daily) Group B (twice daily) Hydrotherapy Group LOS Day 3 ILOA * * Day 6 ILOA NOTE: Values are mean SD. Hydrotherapy group not included in the data analysis. Data are presented for observational comparison only. LOS analyzed by using independent t test; ILOA analyzed using Mann-Whitney U test. Abbreviation: ILOA, Iowa Level of Assistance Scale. *P.05.

5 1656 PHYSIOTHERAPY AFTER TOTAL HIP REPLACEMENT, Stockton 10, and 25m) regardless of assistance required or walking aid used. This renders comparison of results between subjects difficult. Freburger 7 performed an audit of medical databases in the United States to investigate the relationship between use of physiotherapy and outcome of care in patients after THR. The audit yielded data from 7495 patients. Analysis revealed that increased physiotherapy input was directly related to decreased cost of care and increased possibility of direct discharge home. Although this report provided sound information, the use of secondary databases makes it difficult to verify the accuracy of data. Moreover, the results pertain to a single national health scheme; the Australian Health system and physiotherapy input is significantly different to the United States of America. There have been very few studies evaluating the effect of increased physiotherapy in the early postoperative period on functional outcome and LOS. Most studies in the area were carried out over a decade ago. 6-8 LOS after THR has significantly reduced over the last decade. 2 Study Limitations A hydrotherapy arm was not included in the initial study design because plans for hospital expansion included the closure of the hydrotherapy pool before completion of data collection. Power calculations for sample size were estimated for 2-group analysis only. Thus, the hydrotherapy data were included purely as a descriptive additive to this study and are not included in the statistical analysis. This did not affect the outcome of this study because the aim was to look at the effect of increased physiotherapy, not a comparison of land- versus water-based therapy. Where possible, the assessor was blinded to group allocation. All other staff (nursing and other allied health) were blinded to patient group to ensure that patients received equitable treatment, especially to ensure that the group receiving once-daily physiotherapy did not receive additional walks. In retrospect, this was not an issue because regardless of group, patients did not receive additional walks until they were independent. Results may vary in institutions where staff other than physiotherapists provide additional mobility training. Two previous studies 9,10 have found that bed exercises did not add to the effectiveness of a mobility program for patients after elective primary hip arthroplasty in terms of hip pain, range, and function. This study included bed exercises but not as a major focus on treatment. However, eliminating bed exercises and concentrating on functional activities may have demonstrated a greater difference between the once-daily and twice-daily treatment groups because patients may have more energy to concentrate on the functional-based program. CONCLUSIONS This study demonstrates that increased physiotherapy in the initial postoperative period results in a statistically significant earlier achievement of functional milestones at day 3. However, this difference was not clinically significant and did not result in improved functional outcome at day 6 or decreased LOS. In this study, twice-daily physiotherapy in the initial postoperative period after primary THR did not result in decreased LOS or improved functional outcome at discharge. Future studies need to be conducted to identify those patients who would benefit from fast-track early discharge and to evaluate the effect of increased physiotherapy input in that group. Acknowledgements: We thank the members of the Physiotherapy Department who were involved in treating the patients. APPENDIX 1: IOWA LEVEL OF ASSISTANCE SCALE Tasks Supine to sitting on the edge of the bed Sitting on the edge of the bed to standing Walking 4.57m Climbing up and down 3 steps Time taken to walk 13.4m Ordinal Scale and Definitions for Level of Assistance 0 Independent No assistance or supervision is necessary to safely perform the activity with or without assistive devices, aids, or modifications. 1 Standby Nearby supervision is required for the safe performance of the activity; no contact is necessary. 2 Minimal One point of contact is necessary for the safe performance of the activity, including helping with the application of the assistive device, getting leg(s) on or off the leg rest, and stabilizing an assistive device. 3 Moderate Two points of contact necessary (by 1 or 2 persons) for the safe performance of the activity. 4 Maximal Significant support is necessary at a total of 3 or more points of contact (by 1 or more people) for the safe performance of the activity. 5 Failed Attempted activity but failed with maximal assistance. 6 Not tested For medical reasons or reasons of safety, the test was not attempted. Contact Any physical contact between the therapist and the patient or the assistive device. *Time to walk 13.4m. Ordinal Scale for Assistive Device 0 No assistive device 1 One stick or crutch 2 Two sticks 3 Two elbow crutches 4 Two crutches 5 Frame Ordinal Scale for Ambulation Velocity* 0 20s s s s s s 6 70s Range of Scores Minimal score: if the patient was independent in all 5 tasks (ie, level of assistance score 0) plus did not require an assistive device for the 4 tasks that involved standing or mobilizing (ie, assistive device score 0), the total score (5 0) for level of assistance score (4 0) for assistive device score, which equals 0.

6 PHYSIOTHERAPY AFTER TOTAL HIP REPLACEMENT, Stockton 1657 APPENDIX 1: IOWA LEVEL OF ASSISTANCE SCALE (Cont d) Maximal score: if the patient was unable to attempt any of the 5 tasks for medical reasons or reasons of safety (ie, level of assistance score 6) and the assistive device for the 4 tasks that involved standing or mobilizing would have been a frame (ie, assistive device score 5), the total score (5 6) for level of assistance score (4 5) for assistive device score, which equals 50. References 1. Segal L, Day SE, Chapman AB, Osborne RH. Can we reduce disease burden from osteoarthritis? Med J Aust 2004;180(Suppl 5):S National Joint Replacement Registry. Annual report. Adelaide: Australian Orthopaedic Association; Peck CN, Foster A, McLauchlan GJ. Reducing incision length or intensifying rehabilitation: what makes the difference to length of stay in total hip replacement in a UK setting? Int Orthop 2006; 30: Brander VA, Fitzgerald Mullarkey C. Rehabilitation after total hip replacement for osteoarthritis. Phys Med Rehabil State Art Rev 2002;16: Ganz SB, Backus SI, Benick RA, Espinal A. Functional recovery following uncomplicated unilateral total hip arthroplasty in older patients. Top Geriatr Rehabil 2004;20: Peerbhoy D, Keane P, Maciver K, Shenkin A, Hall GM, Salmon P. The systematic assessment of short-term functional recovery after major joint arthroplasty. J Qual Clin Practice 1999;19: Freburger JK. An analysis of the relationship between the utilisation of physical therapy services and outcomes of care for patients after total hip arthroplasty. Phys Ther 2000;80:5: Munin MC, Rudy TE, Glynn NW, Crossett LS, Rubash HE. Early inpatient rehabilitation after elective hip and knee arthroplasty. JAMA 1998;279:11: Jesudason C, Stiller K. Are bed exercises necessary following hip arthroplasty? Aust J Physiother 2002;48: Smith TO, Mann CJ, Clark A, Donnell ST. Bed exercises following total hip replacement: a randomised controlled trial. Physiotherapy 2008;94: Wylde V, Learmonth ID, Cavendish VJ. The Oxford Hip score: the patients perspective. Health Qual Life Outcomes 2005;3: Field RE, Cronin MD, Singh PJ. The Oxford Hip scores for primary and revision hip replacement. J Hand Surg [Br] 2005;87: Dawson J, Fitzpatrick R, Carr A, Murray D. Questionnaire on the perceptions of patients about total hip replacement. J Hand Surg [Br] 1996;78: Shields RK, Enloe LJ, Evans RE, Smith KB. Reliability, validity and responsiveness of functional tests in patients with total joint replacement. Phys Ther 1995;75: Supplier a. SPSS Inc, 233 S Wacker Dr, 11th Fl, Chicago, IL

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