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M.A. Risberg, PT, MA, PhD, Nor- Intervention. All participants attended a patient education program consisting of 3 group
wegian Research Center for Active meetings led by 2 physical therapists. Two other physical therapists were responsible for
Rehabilitation, Department of providing the exercise therapy program, consisting of 2 or 3 weekly sessions of strengthening,
Orthopaedics, Oslo University functional, and stretching exercises over 12 weeks. Both interventions were conducted at a
Hospital. sports medicine clinic.
[Svege I, Fernandes L, Nordsletten
L, et al. Long-term effect of exer- Measurements. Outcome measures included ROM, isokinetic muscle strength, predicted
cise therapy and patient educa- maximal oxygen consumption determined with the Astrand bicycle ergometer test, and
tion on impairments and activity distance and pain during the Six-Minute Walk Test (6MWT). Follow-up assessments were
limitations in people with hip conducted 4, 10, and 29 months after enrollment by 5 physical therapists who were unaware
osteoarthritis: secondary outcome of group allocations.
analysis of a randomized clinical
trial. Phys Ther. 2016;96:818
827.] Results. No significant group differences were found for ROM, muscle strength, predicted
maximal oxygen consumption, or distance during the 6MWT over the follow-up period, but
2016 American Physical Therapy the exercise group had less pain during the 6MWT than the control group at 10 months (mean
Association difference8.5 mm; 95% confidence interval16.1, 0.9) and 29 months (mean differ-
Published Ahead of Print: ence9.3 mm; 95% confidence interval18.1, 0.6).
December 17, 2015
Accepted: December 6, 2015 Limitations. Limitations of the study were reduced statistical power and 53% rate of
Submitted: February 11, 2015 adherence to the exercise therapy program.
Discussion
The main findings of the present study
were that a 12-week exercise therapy
program given in addition to patient edu-
cation provided no beneficial long-term
effect over patient education only for
ROM, muscle strength, indirectly mea-
sured maximal oxygen uptake, or dis-
tance covered in the 6MWT. Participants
who received both exercise therapy and
patient education reported significantly
less pain during the 6MWT at the 10- and
29-month follow-up assessments than
participants who received patient educa-
tion only.
Table 2.
Estimated Mean Differences Between Exercise Therapy Group and Control Groupa
Variable 4 mo 10 mo 29 mo Pc
Aggregated 15.6 (3.2, 34.4) 8.5 (12.1, 29.1) 5.4 (28.8, 18.0) .252
Extension 0.1 (3.1, 3.3) 1.7 (5.2, 1.8) 0.9 (4.9, 3.0) .888
Flexion 4.7 (1.4, 10.9) 2.1 (4.6, 8.8) 0.5 (7.2, 8.1) .072
Internal rotation 3.0 (2.9, 8.9) 4.7 (1.7, 11.1) 0.1 (7.2, 7.4) .543
External rotation 5.4 (0.5, 10.3) 0.1 (5.4, 5.2) 2.9 (9.0, 3.1) .116
Abduction 2.3 (1.0, 5.5) 1.8 (1.7, 5.3) 0.4 (4.4, 3.6) .393
Adduction 1.4 (1.2, 4.0) 1.7 (1.1, 4.6) 1.7 (4.9, 1.6) .468
Knee extension 3.3 (12.3, 18.9) 11.6 (28.5, 5.2) 5.7 (25.5, 14.1) .672
Knee flexion 1.8 (11.3, 7.7) 7.1 (17.4, 3.2) 4.1 (16.2, 7.9) .647
Hip extension 4.9 (27.3, 17.5) 23.1 (49.4, 3.2) 6.0 (35.4, 23.4) .450
Hip flexion 0.3 (12.3, 11.8) 12.2 (26.3, 1.9) 1.9 (17.7, 13.9) .472
Predicted VO2max (L/min) 0.1 (0.2, 0.4) 0.1 (0.2, 0.4) 0.2 (0.1, 0.6) .464
6MWT for distance (m) 0.2 (40.7, 40.3) 1.8 (46.6, 42.9) 8.7 (42.7, 60.0) .801
Pain on VAS during 6MWT (mm) 4.4 (11.3, 2.4) 8.5 (16.1, 0.9) 9.3 (18.1, 0.6) .018d
a
ROMrange of motion, VO2maxmaximal oxygen consumption, 6MWTSix-Minute Walk Test, VASvisual analog scale.
b
Mean for control group subtracted from mean for exercise group.
c
Linear mixed model (variance component model) with time and time group as fixed effects and time as random-effect intercept and slope. P values are
for time group.
d
Significance level: P.05.
exercise program. Additionally, the exer- and has been found to be associated with repetitions, aimed at 70% to 80% of the
cises included in the program may have hip function and disability.6,7,34 There- 1-repetition maximum.36 The lack of an
been ineffective for initiating changes in fore, flexibility and stretching exercises effect on isokinetic muscle strength may
the selected secondary outcome mea- were included in the exercise therapy have been related to inadequate dosage
sures, and the dosage, progression, and program. The lack of a manual compo- and progression of the strengthening
execution of the exercises may have nent during stretching may have resulted exercises. Only 53% of participants were
been inadequate. Furthermore, the PASE in an inadequate stimulus and, therefore, adherent to the exercise therapy pro-
score and the reported engagement in may account for the lack of effect on gram, suggesting that many did not exer-
exercise or physical activity were similar ROM. Hoeksma et al35 reported that man- cise frequently enough, as 2 or more ses-
in the 2 groups and did not increase ual therapy and stretching had a better sions per week seem to be required to
substantially from the baseline assess- effect on ROM than exercise, whereas achieve increased muscle strength.37
ment to the 4-month follow-up assess- French et al15 reported that manual ther- Additionally, resistance and progression
ment. These data may suggest that par- apy in addition to exercise was as effec- may have been insufficient, resulting in
ticipants in the exercise group did not tive as exercise only. an intensity below the required 60% to
increase their overall exercise dosage by 80% of the 1-repetition maximum.37
adding the specific exercise therapy pro- Despite the fact that resistance exercises However, Fukumoto et at38 found that
gram to their usual activities but rather represented a key component of the high-velocity strength training and low-
that they replaced some of their previous exercise therapy program, no between- velocity strength training were equally
weekly activities with 2 weekly sessions group difference in isokinetic concentric beneficial for improving strength in
of exercise therapy. muscle strength of the knee and hip was patients with hip OA. Furthermore, the
found. The exercise therapy program strengthening component of the func-
Impaired ROM has been demonstrated in applied in the present study comprised 7 tional exercises included in the exercise
people with hip OA relative to people resistance exercises,17 and participants therapy program may have been inade-
who are healthy6,7 and normative data29 were instructed to perform 3 sets with 8
Table 3.
Outcome Measures at Baseline and Follow-Up Assessments for Exercise Therapy Group and Control Groupa
X (SD) for:
Baseline 4 mo 10 mo 29 mo Baseline 4 mo 10 mo 29 mo
Variable (n55) (n54) (n48) (n40) (n54) (n50) (n39) (n28)
Hip ROM ()
Aggregated 234.6 (43.8) 235.3 (49.4) 231.9 (55.2) 216.8 (44.7) 222.0 (46.6) 219.6 (43.6) 223.4 (52.5) 222.1 (51.9)
Extension 1.5 (7.9) 1.8 (8.3) 1.9 (9.7) 7.3 (6.5) 1.6 (8.6) 1.7 (7.9) 3.6 (8.6) 8.2 (7.1)
Flexion 126.5 (13.8) 123.3 (15.3) 119.8 (16.4) 116.0 (13.4) 119.1 (17.3) 118.5 (15.3) 117.7 (17.6) 115.5 (17.0)
Internal rotation 33.2 (14.4) 35.3 (14.5) 33.5 (15.9) 28.5 (14.0) 32.8 (15.6) 32.3 (15.7) 28.8 (16.0) 28.3 (13.7)
External rotation 27.7 (13.4) 31.9 (12.7) 32.0 (15.5) 24.4 (10.5) 24.4 (11.2) 26.5 (11.7) 32.1 (13.0) 27.3 (9.5)
Abduction 23.9 (8.6) 23.7 (7.5) 24.2 (7.9) 23.3 (8.4) 22.2 (9.0) 21.4 (7.1) 22.4 (9.3) 23.7 (8.6)
Adduction 21.9 (6.1) 20.7 (6.4) 20.5 (7.0) 17.4 (7.8) 21.9 (6.8) 19.3 (5.7) 18.8 (6.3) 19.0 (7.9)
Knee extension 116.7 (35.9) 123.4 (38.9) 120.2 (38.3) 136.8 (38.8) 120.6 (44.2) 120.1 (43.8) 131.1 (41.9) 142.5 (40.1)
Knee flexion 67.7 (24.4) 69.6 (25.1) 69.2 (24.3) 76.9 (23.0) 68.7 (24.4) 71.4 (25.5) 76.0 (26.4) 81.1 (25.1)
Hip extension 157.0 (58.4) 158.5 (56.4) 152.3 (49.2) 145.6 (51.1) 163.7 (65.9) 163.4 (60.4) 173.6 (64.1) 147.3 (61.5)
Hip flexion 91.4 (31.2) 90.7 (27.7) 84.0 (27.8) 85.0 (25.4) 96.1 (36.5) 90.9 (35.5) 96.8 (32.6) 84.3 (31.8)
Predicted VO2max (L/min) 2.3 (0.1) 2.4 (0.1) 2.3 (0.1) 2.3 (0.1) 2.4 (0.1) 2.5 (0.1) 2.4 (0.1) 2.6 (0.1)
6MWT for distance (m) 632.6 (103.8) 668.1 (99.5) 688.3 (16.6) 669.6 (88.4) 657.4 (95.0) 668.3 (100.4) 690.2 (101.3) 660.9 (141.1)
Pain on VAS during 23.1 (20.2) 15.1 (16.7) 12.8 (17.6) 14.4 (16.7) 19.4 (14.9) 19.6 (16.0) 21.3 (20.5) 23.7 (19.7)
6MWT (mm)
a
ROMrange of motion, VO2maxmaximal oxygen consumption, 6MWTSix-Minute Walk Test, VASvisual analog scale.
quate to improve maximum isokinetic improve walking capacity in patients clinically important improvement on the
concentric muscle strength. with lower limb OA.38,43 VAS in patients with hip OA was esti-
mated to be 15.3 mm45 but was found
The Astrand bicycle ergometer test and The previously reported results for the to be affected by the degree of symptom
the 6MWT for distance can both be con- primary outcome measure of the ran- severity. In patients with less pain at
sidered to represent levels of physical domized trial on which the present study baseline, comparable to that of partici-
fitness. No between-group difference was based revealed that exercise therapy pants with mild to moderate symptoms
was found for either of them over the had no additional effect on WOMAC pain at the time of enrollment in the present
study period. Walking speed and dis- over patient education only.13 Although study, the threshold was estimated to be
tance have been suggested to be some- the WOMAC can be considered to rep- 7.2 mm.45 These data indicate that the
what decreased in patients with hip OA resent an overall measure of self- mean estimated between-group differ-
relative to people who are healthy.6,7,39 perceived pain, including pain at rest, ences at the 10- and 29-month follow-up
However, the 6MWT results for partici- the assessment of pain during the 6MWT assessments were clinically relevant.
pants in the present study were compa- was included to evaluate activity-related
rable to normative values for adults who pain. Activity-related pain is an important Although no additional effect of exercise
are healthy,3133,40 suggesting that the component of OA,44 but previous studies therapy was revealed for the primary out-
potential for improvement was some- reported conflicting results regarding the come measure (WOMAC pain), partici-
what limited. Furthermore, specific exer- effect of exercise therapy on levels of pants who received exercise therapy
cises targeting walking activities or spe- activity-related pain.12,15,16 In the present and patient education had better self-
cific types of training aimed at increasing study, exercise therapy seemed to pro- reported physical function than those
cardiovascular fitness were not included vide a beneficial long-term effect on pain who received patient education
in the exercise therapy program. Results during walking, with the exercise group only.13,46 Furthermore, we demonstrated
regarding the importance of quadriceps having 8.5 mm and 9.3 mm less pain on a lower 6-year risk for THR surgery in the
muscle strength for walking speed are the VAS during the 6MWT at the 10- and exercise group,46 indicating a favorable
inconsistent,41,42 but it has been sug- 29-month follow-up assessments, respec- effect of exercise therapy on disease pro-
gested that resistance training may tively. The overall threshold for minimal gression. The lack of an effect of exercise
therapy on ROM, muscle strength, indi- tions in both groups at all follow-up ment.13 Post hoc power calculations
rectly measured maximum oxygen con- assessments and the wide confidence based on estimated smallest detectable
sumption, and the 6MWT for distance intervals for the estimated means indi- changes or minimal important changes
and the results reported in previous pub- cated that large individual differences for aggregated ROM,53 isokinetic knee
lications for this trial appear to be some- were present at all follow-up assessments extension muscle strength,57 the
what inconsistent. In summary, benefi- and for the treatment effect. 6MWT,50,58 and pain on the VAS sug-
cial effects of exercise therapy were gested that the numbers of participants
demonstrated for self-reported function, Self-reported outcome measures are fre- needed in the groups were 66, 60, 42 to
pain during walking, and the need for quently used to evaluate functional 119, and 80, respectively. Hence, the
THR (ie, less need), whereas no addi- impairments and the treatment effect for study was underpowered for detecting
tional effects on self-reported pain, ROM, OA, but according to Wright et al,48 long-term group differences in the sec-
muscle strength, aerobic fitness, or walk- observer-based outcome measures of ondary outcome measures. During the
ing capacity were found. Perceived pain function can provide supplementary follow-up period, 18% of participants in
during activity may influence self- information concerning physical func- the exercise group and 32% of partici-
reported physical function,47 whereas tion. Hence, self-reported and observer- pants in the control group underwent
pain is taken into account to a lesser based outcome measures of function can THR. Therefore, the estimates for the
extent in observer-driven clinical and be considered to be complementary long-term follow-up assessments must be
performance-based tests.48 Joint pain in rather than competing.49 The secondary interpreted cautiously, as the presum-
early OA is typically described as being outcome measures used in the present ably poorer preoperative results for par-
exacerbated by activity and relieved by study were chosen on the basis of the ticipants who underwent THR were not
rest.44 Hence, the favorable effect on reduced ROM, isokinetic knee extension taken into account. This situation may
pain during walking in the present study muscle strength, and walking capacity in have led to an overestimation of the
may be associated with the previously patients with hip OA relative to people mean estimates at the latest follow-up
demonstrated effect on self-reported who are healthy7 and normative assessments in both groups. More impor-
physical function.13 However, the bene- data.29,30 Acceptable reliability has been tantly, the fact that more participants
ficial results were not reflected by demonstrated for the 6MWT50 and isoki- (with poorer preoperative results) in the
changes in ROM, muscle strength, or the netic knee muscle strength assess- control group underwent THR may have
6MWT. It has been suggested that even if ments,51,52 whereas poorer intrarater resulted in an underestimation of the
high-intensity strength training produces and interrater reliability and relatively group differences in favor of the exercise
larger maximal strength adaptations, it large measurement errors have been therapy group. This situation, in addition
does not necessarily improve physical reported for ROM assessments.5355 One to the overall reduced statistical power
function more than low-intensity train- previous study reported acceptable reli- because of the small sample size and a
ing.37 Furthermore, the task specificity of ability for isokinetic hip muscle strength considerable number of missing values
the functional exercises in the exercise assessments, but the protocol in that during the long-term follow-up period,
therapy program may have been decisive study differed from our protocol in that it may have increased the risk of type II
for the improvement of self-perceived had a larger hip joint testing range.56 errors. Furthermore, multiple tests be-
physical function but may have had a Recently, a consensus-derived set of cause of the repeated use of several sec-
limited effect on the specific measures of performance-based tests for assessing ondary outcome measures over a
ROM and muscle strength. physical function in patients with hip or 29-month follow-up periodincreased
knee OA were suggested as suitable out- the risk of type I errors. Hence, the pres-
The findings of the present study are come measures for use in clinical trials of ent study should be interpreted as an
applicable to people with symptomatic patients with lower limb OA: the 30-s exploratory study, and future studies are
and radiographically evident hip OA, chair stand test, the 40-m fast-paced walk needed to verify or reject the study
with mild to moderate symptoms, but test, a stair-climb test, the Timed Up & hypothesis.
without concomitant knee or back pain. Go Test, and the 6MWT.49 Further stud-
ies evaluating the appropriateness of Changes in isokinetic muscle strength
In participants with symptomatic and clinical and performance-based outcome during the follow-up period must be
radiographically evident hip OA, increas- measures in clinical trials and studies interpreted with caution, as a different
ing impairments and a mean decline in evaluating the effect of exercise interven- device was used for isokinetic strength
physical performance over time could tions with various outcome measures in assessment at the 29-month follow-up
have been expected. However, the esti- patients with hip OA are therefore assessment. For the assessment of isoki-
mated mean results suggested that both encouraged. netic muscle strength of the hip, the test-
groups remained relatively stable over ing range was small because of the tech-
time. For a comparison of the treatment The present study had some limitations. nical limitations of the REV6000; the
effect with the time-dependent course of The power calculation was based on the testing range was set at 35 to 75 degrees
the disease, a control group offered no predefined primary outcome of this ran- of hip flexion and, therefore, repre-
treatment should have been included. domized clinical trial, the WOMAC pain sented only about 32% of the mean total
Furthermore, the high standard devia- score at the 16-month follow-up assess- ROM in the sagittal plane. Furthermore,
the fact that 5 different testers per- assessments and research coordinator Kristin 9 Zhang W, Nuki G, Moskowitz RW, et al.
formed the outcome assessments Blstad for study management. They thank OARSI recommendations for the manage-
ment of hip and knee osteoarthritis, part
increased the risk of measurement physical therapist and postdoctoral fellow III: changes in evidence following system-
errors. Ingrid Eitzen for valuable discussions during atic cumulative update of research pub-
the preparation of the article. They also lished through January 2009. Osteoarthri-
acknowledge the Norwegian Sports Medi- tis Cartilage. 2010;18:476 499.
In general, masking of patients and care cine Clinic, Oslo, Norway, for supporting the 10 Fernandes L, Hagen KB, Bijlsma JW, et al.
providers and adequate placebo treat- Norwegian Research Center for Active Reha- EULAR recommendations for the non-
ments are difficult to apply in studies bilitation with rehabilitation and test facilities pharmacological core management of hip
evaluating the effect of exercise interven- and knee osteoarthritis. Ann Rheum Dis.
and research staff. 2013;72:11251135.
tions, including the present study. The
The study was approved by the Regional 11 Fransen M, McConnell S, Hernandez-
rationale for providing the patient edu-
Medical Research Ethics Committee and was Molina G, Reichenbach S. Exercise for
cation program to all participants in the carried out in accordance with the Declara- osteoarthritis of the hip. Cochrane Data-
present study, including participants in base Syst Rev. 2014;4:CD007912.
tion of Helsinki.
the control group, was primarily based 12 Tak E, Staats P, Van HA, Hopman-Rock M.
on ethical considerations. The placebo This study was supported by EXTRA funds The effects of an exercise program for
effect of exercise treatment has not been from the Norwegian Foundation for Health older adults with osteoarthritis of the hip.
and Rehabilitation, through the Norwegian J Rheumatol. 2005;32:1106 1113.
fully estimated but has been suggested to
Rheumatism Association, and by grants from 13 Fernandes L, Storheim K, Sandvik L, et al.
be of some significance.16 However, the Oslo University Hospital. Efficacy of patient education and super-
efficacy of patient education interven- vised exercise vs patient education alone
tions has been found to be negligible or Original trial registration: ClinicalTrials.gov in patients with hip osteoarthritis: a single
NCT00319423; additional trial registration blind randomized clinical trial. Osteoar-
small9; therefore, patient education may thritis Cartilage. 2010;18:12371243.
be considered to have served as a pla- for the long-term follow-up study: Clinical-
Trials.gov NCT01063777. 14 Juhakoski R, Tenhonen S, Malmivaara A,
cebo in the present study. et al. A pragmatic randomized controlled
DOI: 10.2522/ptj.20140520 study of the effectiveness and cost conse-
quences of exercise therapy in hip osteo-
The present study was carried out at a arthritis. Clin Rehabil. 2010; 25:370 383.
sports medicine clinic, with a limited
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