Evaluation of a 12-week app-guided exercise intervention in patients with knee osteoarthritis (re.flex): a study protocol for a randomized controlled trial
Abstract
Current health care demonstrates an insufficient provision and utilization of physical exercises despite their recommendation as a first-line treatment in clinical guidelines for patients with knee osteoarthritis (OA). Mobile health (m-health) technologies offer new opportunities to guide and monitor home-based exercise programs by using mobile devices and inertial sensors in combination with a digital application (app). This study will evaluate patient benefits resulting from the use of the specific digital health application re.flex for patients with knee OA. This monocentric, two-arm, randomized controlled parallel-group trial will evaluate the effectiveness of the app- and sensor-guided exercise program re.flex for patients with moderate-to-severe knee OA. We aim to recruit 200 participants via newspapers, newsletters and information events. Participants will be randomly allocated to the intervention group and the control group in a 1:1 ratio. Participants in the control group will not receive any study intervention or instruction for any change to their previous health care utilization. Despite this, they are allowed to make use of usual care provided by their treating physician. The intervention group comprises a 12-week home training program with three sessions per week in addition to usual care. Exercises will be guided and monitored by use of the training app (re.flex) and two accelerometers that are attached proximally and distally to the affected knee joint. Pre-…
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: 200 participants or records.
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