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Art. Reemplazo de Cadera
Art. Reemplazo de Cadera
Abstract
Background At present, there is an insufficient evidence base to evaluate the effectiveness of physiotherapy following total hip replacement
(THR). This study evaluated the effectiveness of a physiotherapy-supervised functional exercise programme between 12 and 18 weeks
following THR. These time-points coincide with increased functional demand in patients.
Design Adequately powered assessor-blinded randomised controlled trial.
Setting Patients were recruited at a pre-operative assessment clinic and randomised following surgery.
Participants Sixty-three subjects were randomised to either the usual care group (control, n = 31) or the functional exercise + usual care
group (n = 32).
Interventions Patients in the functional exercise group attended a physiotherapy-supervised functional exercise class twice weekly from 12
to 18 weeks following THR. Patients in the control group followed the usual care protocol with no exercise intervention.
Main outcome measurement The main outcome measurement tool was the Western Ontario and McMaster Universities Osteoarthritis Index
(WOMAC) questionnaire, and the secondary outcomes included walking speed, hip abduction dynamometry, Short Form 12 physical and
mental health scores, and visual analogue pain scale score.
Results At 18 weeks post surgery, WOMAC function and walking speed improved significantly more in the functional exercise group [mean
difference −4.0, 95% confidence 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)] than the control
group, but there was no significant difference in hip abductor strength.
Conclusion This study demonstrated that patients who undertake a physiotherapy-led functional exercise programme between 12 and 18
weeks after THR may gain significant functional improvement compared with patients receiving usual care.
Clinical trial registration number NCT01683201.
© 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Keywords: Total hip replacement; Late-stage functional exercise; Postoperative rehabilitation; Physiotherapy
http://dx.doi.org/10.1016/j.physio.2016.01.003
0031-9406/© 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
284 B. Monaghan et al. / Physiotherapy 103 (2017) 283–288
(6MWT)] and Short Form (SF)12 self-reported physical and the fact that some of the tests of normality on the baseline
mental health scores, as described in the previously published scores (Kolmogorov–Smirnov) showed a significant effect,
protocol [19]. it was assumed that the dependent variable was approxi-
Following the literature review [16], a strength assessment mately normal, and as the sample size was greater than 30,
outcome was added in the form of a dynamometry isomet- the general linear model analysis of covariance (ANCOVA)
ric strength test as an additional secondary outcome. Hip would be sufficiently robust to accommodate the approximate
abduction strength was assessed as this has been cited in pre- normality.
vious studies to be positively correlated with self-assessed Parametric tests were therefore deemed to be appropriate
function [6]. The dynamometry measurements of mean and for analysis of all of the outcome measures. ANCOVA models
maximum hip abduction strength were recorded for both were used to compare treatment effects over the 6-week study
hips using a hand-held dynamometer (Power Track 11 Com- period between the functional exercise group and the control
mander, JTECH Medical, Midvale, UT, USA), as described group. In all tests, the independent variable was allocation to
by Thorborg et al. [20]. This has been shown to be reliable either the functional exercise group or the control group, and
and valid for the measurement of hip abduction. The patient the dependent variables were WOMAC questionnaire, SF12,
was positioned in a supine position, with the hip to be tested 6MWT, visual analogue scale and dynamometry recordings
in the neutral position. The test leg and the resistance point at Week 18. Baseline measures were included as a covariate,
were positioned over the end of the table. The opposite leg and surgical approach (posterior/anterolateral) was included
was flexed. The patient held the plinth with both hands. The as a random factor.
principal investigator applied resistance in a fixed position,
and the patient abducted maximally against the dynamome-
Results
ter and the examiner. Resistance was applied at a premarked
point 5 cm proximal to the lateral malleolus. The standard- Sixty-three patients completed the study; 31 in the con-
ised command of ‘go, push, push, push, push and relax’ was trol group and 32 in the functional exercise group. At Week
used on each patient. 12 (baseline), there was no significant difference between
For patients randomised to the functional exercise group, the functional exercise group and the control group in either
follow-up rehabilitation was performed at one of three outly- the parametric or non-parametric tests (see Table 1). At
ing community hospital sites. Informed consent was obtained Week 18, the function component of the WOMAC score was
from 72 patients, but nine patients did not complete the base-
line assessment at Week 12. Table 1
Demographic data and baseline scores for functional exercise and control
groups.
Sample size
Functional Control group P-value
exercise group
Sample size calculations were based on the physical func-
Sex (% male) 63 74 0.33
tion subscale of the WOMAC questionnaire. The minimal
clinically important difference (MCID) on the WOMAC Surgical approach, %
questionnaire has been established in the literature to be Anterolateral 69 74 0.64
Posterior 31 26 0.64
−10.4, with a standard deviation (SD) of 13.6, as described
in the study protocol [19]. The sample size was calculated
Mean (SD) Mean (SD) P-value
requiring a power of 80% in a two-tailed test with signifi-
cance of 0.05. The effect size was calculated as 10.4 (MCID) Age (years) 68 (8) 69 (9) 0.41
Weight (kg) 79 (15) 82 (20) 0.56
divided by 13.6 (SD), and found to be 0.764 or a moder- Height (cm) 166 (8) 167 (9) 0.61
ate/large effect. The sample size required was then calculated WOMAC pain 2.5 (2.2) 1.8 (2.1) 0.38
to be 27 patients per group or 54 patients in total, and this WOMAC stiffness 2.2 (1.2) 2.4 (1.2) 0.40
was increased to 60 to allow for attrition. WOMAC function 10.7 (9.5) 9.7 (7.1) 0.99
Statistical analysis was conducted using Statistical 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
Package for the Social Sciences Version 20 (IBM Corp., Dyn (MVNOP) (lbs) 14.5 (4.6) 16.0 (5.9) 0.26
Armonk, NY, USA). Two patients enrolled in the interven- 6MWT (m) 443.8 (71.9) 439.7 (92.5) 0.85
tion group did not receive the intervention, but were analysed SF12 Phy 43.7 (9.2) 42.8 (9.6) 0.71
in the exercise group according to intention-to-treat princi- VAS (units) 1.5 (2.2) 0.71 (1.3) 0.10
ples. There were 63 patients in total; 32 in the functional Dyn BVOP 13.2 (4.3) 14.5 (5.6) 0.44
Dyn MVOP 12.4 (4.1) 13.7 (5.4) 0.43
exercise group and 31 in the control group. Compliance SF12 55.7 (9.1) 42.7 (9.6) 0.09
with the functional exercise programme was good at 88%
6MWT, 6-minute walk test; WOMAC, Western Ontario and McMaster
(341/384 sessions). Preliminary checks were conducted to Universities Osteoarthritis Index; Dyn, dynamometry; BVNOP, Best value
ensure that the assumptions of normality, linearity, homo- non-operated side; MVOP, Mean value non-operated side; SF12 Phy, Short
geneity of variances, homogeneity of regression slopes and Form 12 physical health score; VAS, visual analogue scale; BVOP, best value
reliable measurement of the covariate were upheld. Despite operated side; MVOP, mean value operated side; SD, standard deviation.
286 B. Monaghan et al. / Physiotherapy 103 (2017) 283–288
Table 2
Comparison of functional exercise and control groups for all outcomes (pre and post intervention).
Variable Functional exercise group Control group Mean difference at P-value
Mean (SD) Mean (SD) Week 18 (95% CI)
Pre n = 32 Post n = 32 Pre n = 31 Post n = 31
WOMAC pain 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
WOMAC stiffness 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
WOMAC function 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
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
VAS (units) 1.5 (2.2) 0.8 (1.4) 0.7 (1.3) 1.0 (1.4) 0.42
BVOPa (lbs) 13.2 (4.3) 15.7 (5.2) 14.5 (5.6) 17.1 (6.7) n = 29b 0.87
BVNOPa (lbs) 15.2 (4.82) 16.4 (5.5) 16.9 (6.3) 19.0 (6.8) n = 29b 0.55
MVNOP (lbs) 14.5 (4.6) 15.9 (5.4) 16.0 (5.9) 18.1(6.6) n = 29b 0.73
SF12 Phys 43.7 (9.1) 49.0 (8.1) 42.8 (9.6) 44.8 (10.5) n = 30b 0.05a
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 Health Score; SF12
Phys, Short Form 12 physical health score; 6MWT, 6-minute walk test.
significantly lower, with a large partial eta squared effect size widely depending on the study population and the follow-
indicating improvement in the functional exercise group com- up timeframe and intervention. Similarly, the literature has
pared with the control group. In addition, distance walked on reported a PASS score in patients with hip osteoarthritis of
the 6MWT and the physical score for SF12 also improved 34.4 for WOMAC function [12], which would indicate that
significantly in the functional exercise group, with moderate the patients in both groups in this study were very satisfied
partial eta squared effect size (see Table 2). This significant with their level of function 18 weeks after THR. However,
difference was present regardless of the surgical approach. no PASS scores for WOMAC function were found for the
There was no significant difference in the stiffness and post-THR group specifically. Again, caution is advised in
pain components of the WOMAC questionnaire between the the interpretation of scores in the absence of publication of
groups. In addition, the between-group differences in visual specific THR figures. This is the first study to evaluate a
analogue scale scores, hip dynamometry and mental health functional exercise programme at this stage of rehabilita-
score for the SF12 were not significantly different. tion following THR using the WOMAC questionnaire as a
primary outcome measurement tool; therefore, direct com-
parison with other trials is not possible.
Discussion Distance walked on the 6MWT was found to differ sig-
nificantly between the intervention group and the control
To the authors’ knowledge, this study is the first ade- group by 27.73 m. This falls within the levels of small and
quately powered randomised controlled trial to demonstrate a meaningful change described in previous work [13]. There-
significant difference in function following a physiotherapy- fore, the clinical relevance of these figures for a group
supervised functional exercise intervention delivered to of patients undergoing rehabilitation following THR has
patients between 12 and 18 weeks after THR. This clinical yet to be proven. Another randomised controlled trial used
finding is very important as physical therapy is increasingly the 6MWT to evaluate the effect of a walking skill train-
deemed to be unnecessary for this patient group. ing programme in patients following THR [24]. This study
Exploration of whether or not a significant difference demonstrated a significant difference (mean of 52 m) in the
reflects a true clinical change for patients was explored distance walked on the 6MWT between the exercise group
by comparing the significant difference with the MCID for and the control group at 5 months and 12 months after
this patient group, and the patient acceptable symptom state surgery. Of note, the exercise programme was performed
(PASS). Examination of the literature demonstrated that the over the same timeframe as the current study (twice weekly
minimal clinical important difference for the function score for 6 weeks), but the duration of each session was twice
of the WOMAC questionnaire varies from 1.33 (scale 0–10) as long (70 vs 35 minutes), and it incorporated a walking
or larger than 12% of baseline [21] score, to −7.9 function programme. Given the similarity between the programmes,
95% CI (−8.8–−5.0) where the total score was normalised to the addition of a walking component to the current study
a 0–100 score [22]. Clinically, however, these scores reflect a is worth exploring, specifically to improve outcome in this
diverse patient group. The disparity in the groups for whom timeframe for the THR population. Other studies [11,24–26]
MCID were reported was the topic of a recent review in phys- reported significant differences in improvements in gait speed
ical therapy [23]. This review concluded that a wide range in their exercise groups following THR; however, none of
of MCIDs has been published relevant to WOMAC scores, the studies commented on the clinical relevance of their
but that caution in interpretation was critical as values vary findings.
B. Monaghan et al. / Physiotherapy 103 (2017) 283–288 287
This randomised controlled trial found no significant dif- scores, and therefore it may not have been adequately pow-
ference in hip abductor strength between the functional ered to detect changes in dynamometry. The figures provided
exercise group and the control group. This is surprising and should assist with accurate calculation of power for these out-
contrary to previous work [17,25,27]. Of note, the mean time comes in future studies. Finally, it is acknowledged that the
from surgery in these studies was longer than that in the patients in this group were not blinded to the study inter-
present study, by which time the natural improvement in vention, and this lack of blinding has the potential to bias
the control group would have slowed and improvement in the results by exaggerating the intervention effects. However,
the experimental group would be more marked. In the cur- given the physical nature of the intervention in a clinically
rent study, both groups showed a significant improvement based study, blinding of participants was not deemed to be
over the 6-week study period, but the difference between possible.
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] evaluated the effect of exercise on Conclusion
low and high compliance with exercise following THR. The
patients in the high-compliance group reported significant The results of this study provide important evidence that
improvement in hip abductor and flexor strength compared patients benefit functionally from attending a programme
with the control group. No significant difference was noted of physiotherapy-led functional exercise rehabilitation from
in the low-compliance group. Although compliance in the 12 to 18 weeks following THR. This study provides evi-
present study was high (88%), the patients in the func- dence of improved patient function and walking speed in
tional exercise group attended twice weekly and completed a patients following THR using assessment tools that incorpo-
programme lasting approximately 35 minutes, which is com- rated patient-reported outcomes. Further studies are needed
parable with the low-compliance group described previously to determine if the favourable outcomes are maintained in the
[25]. Whilst clinical resources may not stretch to supervised long term.
functional exercise classes more than twice weekly, a home
exercise strengthening programme may be needed in addi-
tion to functional exercise if an improvement in strength is Acknowledgements
required. This warrants further exploration in future studies.
In conclusion, Sashika et al. [27] attributed improvement in The authors wish to acknowledge the patients who took
strength to the motivation gained from the discovery of a part in the study without whom this work would not be pos-
difference in the operated and non-operated sides at the ini- sible.
tial evaluation, and this motivated patients to improve for We also wish to acknowledge the work of the Physio-
the second evaluation, even in the absence of any change in therapy Managers; Ms Karen Gunn and Ms Lara-Bourton
exercise routine. This motivation factor was not considered –Cassidy for all their support throughout the project par-
in the current study, but does warrant consideration in future ticularly in the initial stages, and with the randomisation
studies. phase.
We acknowledge the help and support of the Physiother-
Limitations of this study apy staff; Ciara Rowe, and Jacqui Given, and in particular
the supervising therapists Deirdre O Doherty, Lana Brennan,
This study was undertaken in the clinical environment Breda Smith, and Emer Griffin without whom this project
to reflect current practice; this reality is reflected in the would not have been possible.
involvement of a number of surgeons and the surgical
approaches used. Unfortunately, the duration of follow-
We acknowledge the help and assistance of all the nurs-
up was also dictated by clinical constraints, and does not
allow for assessment of longer-term outcomes. The mean ing staff in the Orthopaedic ward under the management of
Ms Davnet Madden and Ms Deirdre Carroll and the staff in
difference in the WOMAC function score between the func-
pre-assessment Ms Peig Banville and Ms Ann Birch for their
tional exercise group and the control group in this study
help with initial patient recruitment.
was small (4.0) compared with other published studies
Finally the authors wish to acknowledge the support of
[22,23], so the true clinical difference between the reha-
the Orthopaedic Consultants at Our Lady’s Hospital Navan;
bilitation groups is not clear cut. It is also acknowledged
Mr Harrington, Mr Walshe, Mr Awan, Mr Mahapatra,
that the exercise levels in the control group were not
Mr Khan and Mr Zubovic for allowing their patients to take
measured specifically, and this could confound the study
findings. part in this study.
Further adequately powered studies using single surgeons Ethical approval: Ethical approval for this study was pro-
and identical implants and surgical approaches would prove vided by the Ethics Committee of the Dublin North East
very useful to verify the findings of this study. It is noteworthy Hospital Group of the Health Service Executive in November
that the power of this study was based on WOMAC and SF12 2013, prior to commencement of the study.
288 B. Monaghan et al. / Physiotherapy 103 (2017) 283–288
Funding: This study was funded by a research training fel- knee and hip osteoarthritis: the patient acceptable symptom state. Ann
lowship for healthcare professional’s award 2012–2014 as Rheum Dis 2005;64:34–7.
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Conflict of interest: None declared. adults. J Am Geriatr Soc 2006;54:743–9.
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Physiotherapy provision following discharge after total hip and total
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Appendix A. Supplementary data
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