Accepted Manuscript

Title: Randomised controlled trial to evaluate a

physiotherapy-led functional exercise programme after total
hip replacement

Author: B. Monaghan P. Cunningham P. Harrington W. Hing

C. Blake T. Cusack

PII: S0031-9406(16)00031-6
DOI: http://dx.doi.org/doi:10.1016/j.physio.2016.01.003
Reference: PHYST 895

To appear in: Physiotherapy

Received date: 19-6-2015

Accepted date: 4-1-2016

Please cite this article as: Monaghan B, Cunningham P, Harrington P, Hing W,

Blake C, Cusack T, Randomised controlled trial to evaluate a physiotherapy-led
functional exercise programme after total hip replacement, Physiotherapy (2016),
http://dx.doi.org/10.1016/j.physio.2016.01.003

This is a PDF file of an unedited manuscript that has been accepted for publication.
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1 Randomised controlled trial to evaluate a physiotherapy-led

2 functional exercise programme after total hip replacement

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B. Monaghana,*, P. Cunninghamb, P. Harringtonc, W. Hingd, C. Blakee, T. Cusacke

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4

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5

a
6 Department of Physiotherapy, Our Lady’s Hospital, Navan, Co Meath, Ireland

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b
7 Department of Radiology, Our Lady’s Hospital, Navan, Co Meath, Ireland

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8 Department of Orthopaedics, Our Lady’s Hospital, Navan, Co Meath, Ireland

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9 Faculty of Health and Sciences and Medicine, Bond University, Robina, QLD, Australia
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10 School of Public Health, Physiotherapy and Population Science, University College Dublin,
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11 Belfield, Dublin, Ireland

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18

*
19 Corresponding author. Address: Department of Physiotherapy, Our Lady’s Hospital, Navan, Co Meath, Ireland.

20 E-mail address: [email protected] (B. Monaghan).

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21 Abstract

22 Background At present, there is an insufficient evidence base to evaluate the effectiveness of

23 physiotherapy following total hip replacement (THR). This study evaluated the effectiveness

24 of a physiotherapy-supervised functional exercise programme between 12 and 18 weeks

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25 following THR. These time-points coincide with increased functional demand in patients.

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26 Design Adequately powered assessor-blinded randomised controlled trial.

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27 Setting Patients were recruited at a pre-operative assessment clinic and randomised following

28 surgery.

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29 Participants Sixty-three subjects were randomised to either the usual care group (control,

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30 n=31) or the functional exercise + usual care group (n=32).

31 Interventions Patients in the functional exercise group attended a physiotherapy-supervised

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32 functional exercise class twice weekly from 12 to 18 weeks following THR. Patients in the

33 control group followed the usual care protocol with no exercise intervention.
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34 Main outcome measurement The main outcome measurement tool was the Western Ontario
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35 and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, and the secondary

36 outcomes included walking speed, hip abduction dynamometry, Short Form 12 physical and
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37 mental health scores, and visual analogue pain scale score.

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38 Results At 18 weeks post surgery, WOMAC function and walking speed improved

39 significantly more in the functional exercise group [mean difference -4.0, 95% confidence
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40 interval (CI) -7.0 to 1.0 (P<0.01); mean difference 21.9 m, 95% CI 0.60 to 43.3 (P<0.04)]

41 than the control group, but there was no significant difference in hip abductor strength.

42 Conclusion This study demonstrated that patients who undertake a physiotherapy-led

43 functional exercise programme between 12 and 18 weeks after THR may gain significant

44 functional improvement compared with patients receiving usual care.

45 Clinical Trial Registration Number NCT01683201.

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46

47 Keywords: Total hip replacement; Late-stage functional exercise; Postoperative

48 rehabilitation; Physiotherapy

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<A>Introduction

Total hip replacement (THR) is a successful surgical procedure performed for end-stage

arthritis. Rates of THR are increasing internationally, with 86,488 replacements performed in

the UK in 2012 [1]. Similar figures have been reported in the Republic of Ireland, where

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approximately 117/100,000 population underwent THR in 2011 [2].

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In most cases, THR provides improved quality of life, pain relief and improved

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function [3,4]. Pain, physical impairment, gait change and reduced muscle strength have also

been reported at 1- and 2-year intervals, even in groups who received physical therapy as part

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of their early rehabilitation programme [5–7]. Postoperatively, a number of studies have

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reported functional problems, in some cases up to 1 year following surgery [4,5].

Dissatisfaction with outcome following THR is reported to be 7–8%, and more recent
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evidence has correlated patient satisfaction with postoperative levels of function [2,8,9].

Traditionally, physical therapy has been a routine part of patient rehabilitation

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following THR [10–13]. More recently, the physiotherapy provision for this clinical group
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has been reduced across the UK (Artz et al), with few centres now offering physiotherapy

follow-up after surgery. A number of systematic reviews have failed to establish the
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effectiveness of physical therapy [10,14–16]. All reviews reported insufficient evidence to

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establish the effectiveness of therapeutic intervention, and noted the poor quality of the trials

included.
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A recent systematic review which informed the current study focused on patients in

the post-acute stage of recovery [15], and found low-grade evidence that a rehabilitation

programme at this stage after THR may serve to improve gait speed and hip abductor

strength.

As such, this single-blinded randomised controlled trial was designed with the

primary aim of evaluating the effectiveness of an outpatient physiotherapy-supervised

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functional exercise programme in the post-acute stage of recovery, and was set in the period

from 12 to 18 weeks after THR. The specific primary outcomes evaluated were pain, stiffness

and physical function.

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<A>Study design

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This randomised controlled trial allocated patients to either a 6-week physiotherapy-

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supervised functional exercise + usual care group or a usual care group (control group) after

THR.

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<B>Functional exercise intervention

Three experienced physiotherapists supervised the functional exercise classes at each of the
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three community hospital-based clinical sites. Training was provided prior to the

commencement of classes in the form of a practical workshop, and written illustrated

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manuals were provided that included an exercise log book which was completed by the
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treating therapist at each attendance. This recorded patient compliance with the programme.

During the functional exercise classes, the participants were taught 12 exercises by the
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supervising physiotherapist. The physiotherapist monitored form and exercise intensity,

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progressing the exercises as necessary. Each session was 35 minutes in length. Patients

attended classes twice weekly for 6 weeks, and were not given any additional exercises as a
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home exercise programme. The specific exercise programme in this study was based on an

exercise programme that had previously been shown to improve pain and function in patients

at this stage of recovery after THR [17] (see Table A, online supplementary material).

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<B>Usual care

Both the control group and the functional exercise group followed the usual care pathway.

This involved the provision of an educational and immediate postoperative exercise booklet

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on admission, and assessment by the orthopaedic surgeon at 6 weeks. The exercises outlined

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in the educational booklet for both groups consisted of early postoperative exercises for the

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duration of the hospital stay. These included foot and ankle pumps, static quadriceps, static

gluteal contractions, active hip flexion and hip abduction. Following surgery, all patients are

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advised to walk daily with crutches until review by the orthopaedic surgeon at 6 weeks,

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increasing the distance gradually to approximately 1 mile after 1 month. No instructions for

any additional exercises were given to either group on discharge.

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The inclusion criteria have been published previously [18], and consisted of: patients

who had undergone primary THR for osteoarthritis, aged ≥50 years, able to read and
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understand instructions in English, willing to attend classes twice weekly for 6 weeks, and
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willing to participate in an exercise programme without physical assistance. Exclusion

criteria were: medical instability, underlying terminal disease and suspicion of infection
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following joint replacement. Patients with previous THR or total knee replacement were not
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excluded.

Having gained ethical approval from the Health Service Executive Committee of the
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North East Hospital Group, patients were recruited at the pre-assessment clinic of the elective

orthopaedic regional unit by the principal investigator, and then enrolled fully into the study

12 weeks after surgery. Following a standard interview, a written description of the study was

given to patients, together with a stamped addressed envelope to return their written consent.

This allowed for a cooling-off period. All patients were scheduled for primary THR for

osteoarthritis under the care of one of the seven surgeons in the unit.

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 Randomisation was achieved using a computer-generated random number table.

Concealed allocation was achieved using sequentially numbered envelopes that were

administered by an independent third party (physiotherapy manager). All patients were

contacted directly for baseline assessment at 12 weeks after THR, and those randomised to

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the exercise group were contacted directly by the physiotherapists responsible for conducting

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the exercise classes. Patients were asked not to discuss their group allocation, and were asked

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not to disclose their group allocation until the final outcome assessments had been completed.

All outcome measurements were recorded 12 weeks after surgery (baseline) and 18

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weeks after surgery by the principal investigator, who was blinded to group allocation. The

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primary outcome measurement tool was the Western Ontario and McMaster Universities

Osteoarthritis Index (WOMAC) questionnaire, which consisted of 24 questions on pain

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(scored 0 to 20), stiffness (scored 0 to 8) and function (scored 0 to 68). Secondary outcome

measures were visual analogue pain scale score, walking speed [6-minute walk test (6MWT)]
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and Short Form (SF)12 self-reported physical and mental health scores, as described in the
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previously published protocol [18].

Following the literature review [15], a strength assessment outcome was added in the
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form of a dynamometry isometric strength test as an additional secondary outcome. Hip

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abduction strength was assessed as this has cited in previous studies to be positively

correlated with self-assessed function [6]. The dynamometry measurements of mean and
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maximum hip abduction strength were recorded for both hips using a hand-held

dynamometer (Power Track 11 Commander, JTECH Medical, Midvale, UT, USA), as

described by Thorborg et al. [19]. This has been shown to be reliable and valid for the

measurement of hip abduction. The patient was positioned in a supine position, with the hip

to be tested in the neutral position. The test leg and the resistance point were positioned over

the end of the table. The opposite leg was flexed. The patient held the plinth with both hands.

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Page 7 of 25
The principal investigator applied resistance in a fixed position, and the patient abducted

maximally against the dynamometer and the examiner. Resistance was applied at a

premarked point 5 cm proximal to the lateral malleolus. The standardised command of ‘go

push, push, push, push and relax’ was used on each patient.

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For patients randomised to the functional exercise group, follow-up rehabilitation was

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performed at one of three outlying community hospital sites. Informed consent was obtained

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from 72 patients, but nine patients did not complete the baseline assessment at Week 12.

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<B>Sample size

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Sample size calculations were based on the physical function subscale of the WOMAC

questionnaire. The minimal clinically important difference (MCID) on the WOMAC

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questionnaire has been established in the literature to be -10.4, with a standard deviation (SD)

of 13.6, as described in the study protocol [18]. The sample size was calculated requiring a
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power of 80% in a two-tailed test with significance of 0.05. The effect size was calculated as
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10.4 (MCID) divided by 13.6 (SD), and found to be 0.764 or a moderate/large effect. The

sample size required was then calculated to be 27 patients per group or 54 patients in total,
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and this was increased to 60 to allow for attrition.

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Statistical analysis was conducted using Statistical Package for the Social Sciences

Version 20 (IBM Corp., Armonk, NY, USA). Two patients enrolled in the intervention group
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did not receive the intervention, but were analysed in the exercise group according to

intention-to-treat principles. There were 63 patients in total; 32 in the functional exercise

group and 31 in the control group. Compliance with the functional exercise programme was

good at 88% (341/384 sessions). Preliminary checks were conducted to ensure that the

assumptions of normality, linearity, homogeneity of variances, homogeneity of regression

slopes and reliable measurement of the covariate were upheld. Despite the fact that some of

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the tests of normality on the baseline scores (Kolmogorov–Smirnov) showed a significant

effect, it was assumed that the dependent variable was approximately normal, and as the

sample size was greater than 30, the general linear model analysis of covariance (ANCOVA)

would be sufficiently robust to accommodate the approximate normality.

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Parametric tests were therefore deemed to be appropriate for analysis of all of the

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outcome measures. ANCOVA models were used to compare treatment effects over the 6-

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week study period between the functional exercise group and the control group. In all tests,

the independent variable was allocation to either the functional exercise group or the control

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group, and the dependent variables were WOMAC questionnaire, SF12, 6MWT, visual

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analogue scale and dynamometry recordings at Week 18. Baseline measures were included as

a covariate, and surgical approach (posterior/anterolateral) was included as a random factor.

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<A>Results
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Sixty-three patients completed the study; 31 in the control group and 32 in the functional
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exercise group. Compliance was 88% (341/384 sessions) in the functional exercise group. At

Week 12 (baseline), there was no significant difference between the functional exercise group
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and the control group in either the parametric or non-parametric tests (see Table 1). At Week
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18, the function component of the WOMAC score was significantly lower, with a large

partial eta squared effect size indicating improvement in the functional exercise group
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compared with the control group. In addition, distance walked on the 6MWT and the physical

score for SF12 also improved significantly in the functional exercise group, with moderate

partial eta squared effect size (see Table 2). This significant difference was present regardless

of the surgical approach.

<insert Tables 1 and 2 near here>

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 There was no significant difference in the stiffness and pain components of the

WOMAC questionnaire between the groups. In addition, the between-group differences in

visual analogue scale scores, hip dynamometry and mental health score for the SF12 were not

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significantly different.

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<A>Discussion

To the authors’ knowledge, this study is the first adequately powered randomised controlled

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trial to demonstrate a significant difference in function following a physiotherapy-supervised

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functional exercise intervention delivered to patients between 12 and 18 weeks after THR.

This clinical finding is very important as physical therapy is increasingly deemed to be

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unnecessary for this patient group.

Exploration of whether or not a significant difference reflects a true clinical change

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for patients was explored by comparing the significant difference with the MCID for this
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patient group, and the patient acceptable symptom state (PASS). Examination of the literature

demonstrates that MCID in WOMAC scores vary between 1.33 (scale 0 to 10) or larger than
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12% of baseline [20], to -7.9 function score absolute change 95% confidence interval -8.8 to -
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5.0) (0 to 100) [21]. Clinically, however, these scores reflect a diverse patient group. The

disparity in the groups for whom MCID were reported was the topic of a recent review in
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physical therapy [22]. This review concluded that a wide range of MCIDs has been published

relevant to WOMAC scores, but that caution in interpretation was critical as values vary

widely depending on the study population and the follow-up timeframe and intervention.

Similarly, the literature has reported a PASS score in patients with hip osteoarthritis of 34.4

for WOMAC function [12], which would indicate that the patients in both groups in this

study were very satisfied with their level of function 18 weeks after THR. However, no PASS

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scores for WOMAC function were found for the post-THR group specifically. Again, caution

is advised in the interpretation of scores in the absence of publication of specific THR

figures. This is the first study to evaluate a functional exercise programme at this stage of

rehabilitation following THR using the WOMAC questionnaire as a primary outcome

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measurement tool; therefore, direct comparison with other trials is not possible.

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Distance walked on the 6MWT was found to differ significantly between the

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intervention group and the control group by 27.73 m. This falls within the levels of small and

meaningful change described in previous work [13]. Therefore, the clinical relevance of these

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figures for a group of patients undergoing rehabilitation following THR has yet to be proven.

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Another randomised controlled trial used the 6MWT to evaluate the effect of a walking skill

training programme in patients following THR [23]. This study demonstrated a significant
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difference (mean of 52 m) in the distance walked on the 6MWT between the exercise group

and the control group at 5 months and 12 months after surgery. Of note, the exercise
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programme was performed over the same timeframe as the current study (twice weekly for 6
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weeks), but the duration of each session was twice as long (70 vs 35 minutes), and it

incorporated a walking programme. Given the similarity between the programmes, the
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addition of a walking component to the current study is worth exploring, specifically to

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improve outcome in this timeframe for the THR population. Other studies [11,23–25]

reported significant differences in improvements in gait speed in their exercise groups

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following THR; however, none of the studies commented on the clinical relevance of their

findings.

This randomised controlled trial found no significant difference in hip abductor

strength between the functional exercise group and the control group. This is surprising and

contrary to previous work [17,24,26]. Of note, the mean time from surgery in these studies

was longer than that in the present study, by which time the natural improvement in the

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control group would have slowed and improvement in the experimental group would be more

marked. In the current study, both groups showed a significant improvement over the 6-week

study period, but the difference between groups was small. Evaluation of both groups in the

longer term would be of interest. Previous work on compliance in a similar patient group [25]

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evaluated the effect of exercise on low and high compliance with exercise following THR.

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The patients in the high-compliance group reported significant improvement in hip abductor

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and flexor strength compared with the control group. No significant difference was noted in

the low-compliance group. Although compliance in the present study was high (88%), the

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patients in the functional exercise group attended twice weekly and completed a programme

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lasting approximately 35 minutes, which is comparable with the low-compliance group

described previously [24]. Whilst clinical resources may not stretch to supervised functional
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exercise classes more than twice weekly, a home exercise strengthening programme may be

needed in addition to functional exercise if an improvement in strength is required. This

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warrants further exploration in future studies. In conclusion, Sashika et al. [26] attributed
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improvement in strength to the motivation gained from the discovery of a difference in the

operated and non-operated sides at the initial evaluation, and this motivated patients to
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improve for the second evaluation, even in the absence of any change in exercise routine.
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This motivation factor was not considered in the current study, but does warrant

consideration in future studies.

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<B>Limitations of this study

This study was undertaken in the clinical environment to reflect current practice; this reality

is reflected in the involvement of a number of surgeons and the surgical approaches used.

Unfortunately, the duration of follow-up was also dictated by clinical constraints, and does

not allow for assessment of longer-term outcomes. The mean difference in the WOMAC

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function score between the functional exercise group and the control group in this study was

small (4.0) compared with other published studies [21,22], so the true clinical difference

between the rehabilitation groups is not clear cut. It is also acknowledged that the exercise

levels in the control group were not measured specifically, and this could confound the study

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findings.

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Further adequately powered studies using single surgeons and identical implants and

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surgical approaches would prove very useful to verify the findings of this study. It is

noteworthy that the power of this study was based on WOMAC and SF12 scores, and

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therefore it may not have been adequately powered to detect changes in dynamometry. The

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figures provided should assist with accurate calculation of power for these outcomes in future

studies. Finally, it is acknowledged that the patients in this group were not blinded to the
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study intervention, and this lack of blinding has the potential to bias the results by

exaggerating the intervention effects. However, given the physical nature of the intervention
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in a clinically based study, blinding of participants was not deemed to be possible.

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<A>Conclusion
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The results of this study provide important evidence that patients benefit functionally from
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attending a programme of physiotherapy-led functional exercise rehabilitation from 12 to 18

weeks following THR. This study provides evidence of improved patient function and
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walking speed in patients following THR using assessment tools that incorporated patient-

reported outcomes. Further studies are needed to determine if the favourable outcomes are

maintained in the long term.

<A>Acknowledgements

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The authors wish to acknowledge the work of the physiotherapy managers and the

physiotherapy staff, particularly the supervising therapists, without whom this project would

not have been possible. The authors also wish to acknowledge the patients who took part in

this study, and the orthopaedic ward nursing staff and staff in pre-assessment for their help

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and support. Finally, the authors wish to acknowledge the support of the orthopaedic

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consultants.

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Ethical approval: Ethical approval for this study was provided by the Ethics Committee of

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the Dublin North East Hospital Group of the Health Service Executive in November 2013,

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prior to commencement of the study.
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Funding: This study was funded by a research training fellowship for healthcare

professional’s award 2012–2014 as part of a PhD programme.

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Conflict of interest: None declared.

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 Table 1

Demographic data and baseline scores for functional exercise and control groups

Functional exercise Control group P-value

group

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Sex (% male) 63 74 0.33

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Surgical approach, %

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Anterolateral 69 74 0.64

Posterior 31 26 0.64

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Mean (SD) Mean (SD)

Age (years) 68 (8) 69 (9) 0.41

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Weight (kg) 79 (15) 82 (20) 0.56

Height (cm) 166 (8) 167 (9) 0.61

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WOMAC pain 2.5 (2.2) 1.8 (2.1) 0.38

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WOMAC stiffness 2.2 (1.2) 2.4 (1.2) 0.40

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WOMAC function 10.7 (9.5) 9.7 (7.1) 0.99

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WOMAC total 15.3 (12.0) 14.0 (8.7) 0.98

Dyn (BVNOP) (lbs) 15.2 (4.8) 16.9 (6.3) 0.23

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Dyn (MVNOP) (lbs) 14.5 (4.6) 16.0 (5.9) 0.26

6MWT (m) 443.8 (71.9) 439.7 (92.5) 0.85

SF12 Phy 43.7 (9.2) 42.8 (9.6) 0.71

VAS (units) 1.5 (2.2) 0.71 (1.3) 0.10

Dyn BVOP 13.2 (4.3) 14.5 (5.6) 0.44

Dyn MVOP 12.4 (4.1) 13.7 (5.4) 0.43

18
Page 18 of 25
SF12 55.7 (9.1) 42.7 (9.6) 0.09

6MWT, six-minute walk test; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index; Dyn,

dynamometry; SF12 Phy, Short Form 12 physical health score; VAS, visual analogue scale; BVOP, best value operated

t
side; MVOP, mean value operated side; SD, standard deviation.

ip
cr
us
an
M
d
p te
ce
Ac

19
Page 19 of 25
 Table 2

Comparison of functional exercise and control groups for all outcomes (pre and post intervention)

Variable Functional Control group Mean P-value

exercise
Mean (SD) difference

t
group

ip
at Week 18
Mean (SD)

cr
d (95% CI)

us
Pre n=32 Post n=32 Pre n=31 Post n=31

an
WOMAC 2.5 (2.1) 0.9 (1.5) 1.8 (2.1) 1.6 (2.4) -0.81 (-1.8 to 0.2) 0.10

pain
M
WOMAC 2.1 (1.2) 1.3 (1.2) 2.4 (1.5) 1.7 (1.6) -0.44 (-1.2 to -0.28) 0.20

stiffness
d

WOMAC 10.7 (9.50) 5.4 (6.6) 9.7 (5.09) 8.8 (8.9) -4.0 (-0.71 to 1.0) 0.01a
te

function
p

6MWT (m) 443.8 (71.9) 490.5 (74.6) 439.7 (92.5) =30 b 462.8 (106.4) =29 b 21.9 (0.60 to 43.3) 0.04a
ce

VAS (units) 1.5 (2.2) 0.8 (1.4) 0.7 (1.3) 1.0 (1.4) 0.42
Ac

BVOPa 13.2 (4.3) 15.7 (5.2) 14.5 (5.6) 17.1 (6.7) n=29 b 0.87

(lbs)

BVNOPa 15.2 (4.82) 16.4 (5.5) 16.9 (6.3) 19.0 (6.8) n=29 b 0.55

(lbs)

MVNOP 14.5 (4.6) 15.9 (5.4) 16.0 (5.9) 18.1(6.6) n=29 b 0.73

(lbs)

SF12 Phys 43.7 (9.1) 49.0 (8.1) 42.8 (9.6) 44.8 (10.5) n=30b 0.05a

20
Page 20 of 25
SF12 MHS 55.7 (9.13) 56.38 (8.6) 60.0 (7.53) 58.6 (7.15) n=30b 0.85

a
Significant (P≤0.05).

b
Change in group number from normal.

t
ip
MV, mean value; SD, standard deviation; VAS, visual analogue score; Dyn, dynamometry; BVOP, best value operated side; MHS, Mental

Health Score; SF12 Phys, Short Form 12 physical health score; 6MWT, six-minute walk test.

cr
50

us
an
M
d
p te
ce
Ac

21
Page 21 of 25
Table(s)

Table 1

Demographic data and baseline scores for functional exercise and control groups

Functional exercise Control group P-value

group

t
ip
Sex (% male) 63 74 0.33

Surgical approach, %

cr
Anterolateral 69 74 0.64

us
Posterior 31 26 0.64

Mean (SD) Mean (SD)

Age (years) 68 (8)

an 69 (9) 0.41
M
Weight (kg) 79 (15) 82 (20) 0.56

Height (cm) 166 (8) 167 (9) 0.61

ed

WOMAC pain 2.5 (2.2) 1.8 (2.1) 0.38

WOMAC stiffness 2.2 (1.2) 2.4 (1.2) 0.40

pt

WOMAC function 10.7 (9.5) 9.7 (7.1) 0.99

ce

WOMAC total 15.3 (12.0) 14.0 (8.7) 0.98

Dyn (BVNOP) (lbs) 15.2 (4.8) 16.9 (6.3) 0.23

Ac

Dyn (MVNOP) (lbs) 14.5 (4.6) 16.0 (5.9) 0.26

6MWT (m) 443.8 (71.9) 439.7 (92.5) 0.85

SF12 Phy 43.7 (9.2) 42.8 (9.6) 0.71

VAS (units) 1.5 (2.2) 0.71 (1.3) 0.10

Dyn BVOP 13.2 (4.3) 14.5 (5.6) 0.44

Dyn MVOP 12.4 (4.1) 13.7 (5.4) 0.43

Page 22 of 25
SF12 55.7 (9.1) 42.7 (9.6) 0.09

6MWT, six-minute walk test; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index; Dyn,

dynamometry; SF12 Phy, Short Form 12 physical health score; VAS, visual analogue scale; BVOP, best value operated

side; MVOP, mean value operated side; SD, standard deviation.

t
ip
cr
us
an
M
ed
pt
ce
Ac

Page 23 of 25
 Table 2

Comparison of functional exercise and control groups for all outcomes (pre and post intervention)

Variable Functional Control group Mean P-value

exercise
Mean (SD) difference
group
at Week 18

t
Mean (SD)

ip
d (95% CI)

cr
Pre n=32 Post n=32 Pre n=31 Post n=31

us
WOMAC 2.5 (2.1) 0.9 (1.5) 1.8 (2.1) 1.6 (2.4) -0.81 (-1.8 to 0.2) 0.10

pain an
M
WOMAC 2.1 (1.2) 1.3 (1.2) 2.4 (1.5) 1.7 (1.6) -0.44 (-1.2 to -0.28) 0.20

stiffness
ed

WOMAC 10.7 (9.50) 5.4 (6.6) 9.7 (5.09) 8.8 (8.9) -4.0 (-0.71 to 1.0) 0.01a

function
pt

6MWT (m) 443.8 (71.9) 490.5 (74.6) 439.7 (92.5) =30b 462.8 (106.4) =29b 21.9 (0.60 to 43.3) 0.04a
ce

VAS (units) 1.5 (2.2) 0.8 (1.4) 0.7 (1.3) 1.0 (1.4) 0.42
Ac

BVOPa 13.2 (4.3) 15.7 (5.2) 14.5 (5.6) 17.1 (6.7) n=29b 0.87

(lbs)

BVNOPa 15.2 (4.82) 16.4 (5.5) 16.9 (6.3) 19.0 (6.8) n=29b 0.55

(lbs)

MVNOP 14.5 (4.6) 15.9 (5.4) 16.0 (5.9) 18.1(6.6) n=29b 0.73

(lbs)

SF12 Phys 43.7 (9.1) 49.0 (8.1) 42.8 (9.6) 44.8 (10.5) n=30b 0.05a

Page 24 of 25
SF12 MHS 55.7 (9.13) 56.38 (8.6) 60.0 (7.53) 58.6 (7.15) n=30b 0.85

a
Significant (P≤0.05).

b
Change in group number from normal.

MV, mean value; SD, standard deviation; VAS, visual analogue score; Dyn, dynamometry; BVOP, best value operated side; MHS, Mental

t
Health Score; SF12 Phys, Short Form 12 physical health score; 6MWT, six-minute walk test.

ip
cr
us
an
M
ed
pt
ce
Ac

Page 25 of 25