Comparing treatments for improving physical function in patients who had knee replacement surgery / Sara R. Piva.

Format:

Book

Author/Creator:

Piva, Sara R., author.

Language:

English

Subjects (All):

Outcome assessment (Medical care).

Physical therapy--Ability testing.

Physical therapy.

Physical Description:

1 online resource

Place of Publication:

Washington, DC : Patient-Centered Outcomes Research Institute (PCORI), 2020.

Summary:

BACKGROUND: Total knee replacement (TKR) improves pain and quality of life; however, functional limitations that existed for years before TKR persist after surgery. Progressive and intensive exercise programs can resolve these persistent limitations but are not well tolerated by many patients until later stages (>2 months) after surgery. The evidence about the effectiveness of exercise programs at later stages post-TKR is limited. OBJECTIVES: This study sought to inform the choice of exercise programs for later stages post-TKR and provide evidence to tailor interventions according to patient characteristics. It also compared the outcomes of physical function, activity, and safety between 3 treatment arms, explored heterogeneity of treatment effects, and determined baseline predictors of outcome. METHODS: This was a 3-arm single-blind randomized controlled trial. We randomly assigned 240 individuals 60 years or older, who had had TKR performed at least 2 months previously, to clinic-based physical therapy exercise over 12 weeks (PT), community-based group exercise lasting 12 weeks (community), or usual care (control). The primary outcome of physical function was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-PF). The secondary outcome of physical function was a battery of performance-based tests germane to TKR and additional patient-reported outcomes at 3 and 6 months. Comparisons between arms used linear mixed models and responder analyses tested by χ2. The definition of clinically relevant improvement for the responder analysis used preestablished thresholds on patient global assessment of change and self-reported and performance-based measures of physical function. RESULTS: Although all 3 arms demonstrated substantial and clinically important improvements in all outcomes of physical function during the study, the results for the primary outcome WOMAC-PF did not show benefit from either of the 2 exercise programs. At 3 months, the PT arm demonstrated only a modest −2.1 point improvement (98.3% CI, −4.9 to 0.7) vs control. The community arm demonstrated no benefit when compared with control: 0.1 (98.3% CI, −2.7 to 2.9). The secondary outcome of performance-based function at 3 months demonstrated greater improvement in the PT arm (0.1 z-score units; 98.3% CI, 0.002-0.2) and up to 25% more responders than the community arm, with more improvements in the PT arm (0.3 z-score units; 98.3% CI, 0.1-0.4) and up to 34% more responders than the control arm. The community arm had greater improvement on performance-based tests than the control arm (0.2 z-score units; 98.3% CI, 0.02-0.3) but the responder analysis did not show greater benefit in the community arm relative to control. Most differences were sustained at 6 months. Neither exercise program was associated with serious adverse events. Logistic regression models demonstrated that worse WOMAC-PF scores and more knee extension at baseline were predictors of treatment response. CONCLUSIONS: This study provides new evidence about the safety and effectiveness of late-stage intensive rehabilitation after TKR. Participants in the 2 exercise programs had the same WOMAC-PF scores (ie, primary outcome) as the usual care arm. However, based on the secondary outcomes and responder analysis, participants in the individualized PT arm had greater improvements than those in the community or control arms. The benefits of individualized PT identified by the secondary outcomes require confirmation. LIMITATIONS: The study had a short follow-up of 6 months, which was constrained by the 3-year funding period; however, based on the literature, function would decline unless patients continued to exercise.

Notes:

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