Effectiveness of the Self-Directed mHealth Exercise Intervention re.flex in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Abstract
Abstract Background About 1 in 2 patients with knee osteoarthritis (OA) receives a referral or recommendation for exercise. Digital health applications could counteract this undersupply. Objective We aimed to investigate the effectiveness of a 12-week self-directed mobile health exercise intervention (re.flex) when used in addition to usual care compared to a control group receiving usual care only on pain reduction and improvement in physical function in patients with knee OA. Methods This monocentric, 2-arm, randomized controlled parallel-group trial included patients from Germany with moderate to severe knee OA. Participants were mainly recruited via newspapers. Randomization was 1:1 into an intervention group (re.flex+usual care) and a control group (usual care) using computer-generated blocks. Participants were unmasked to group assignment. The re.flex group conducted a 12-week self-directed app-based and sensor-assisted exercise program with 3 sessions per week in addition to usual care. Primary outcomes were OA-specific knee pain and physical function (using the subscales pain and activities in daily living of the Knee Osteoarthritis Outcome Score, 0‐100) at 3 months. Secondary outcomes included adherence and safety. Multiple imputation was used to account for missing data. Intervention effects were calculated using a baseline-adjusted analyses of covariance (ANCOVA). Bonferroni correction with an alpha level of .025 was applied. Results Between January 25, 2023, and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 195 participants or records.
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