VRCycle: A Feasibility Randomized Controlled Trial Evaluating a Virtual Reality Cycling Intervention in People With Knee Osteoarthritis.

IMPORTANCE: Exercise is recommended as a core treatment for knee osteoarthritis; yet uptake is suboptimal, with identified barriers including pain, difficulty (overly effortful), and boredom. Virtual reality (VR) shows promise in overcoming these barriers, although whether VR-enhanced exercise is acceptable to people with osteoarthritis and feasible in physical therapy settings is unknown. OBJECTIVE: The objective was to assess the feasibility of conducting a clinical trial to evaluate VR-enhanced cycling and explore preliminary efficacy of this intervention. DESIGN: A prospectively registered (ACTRN12624000122550), two-arm feasibility randomized controlled trial was conducted. SETTING: The trial was conducted at a clinical trials facility. PARTICIPANTS: Forty-one participants with painful knee osteoarthritis were enrolled. INTERVENTIONS: Participants were randomized (1:1 ratio) to receive VR-enhanced cycling or traditional (no-VR) cycling, both involving twelve, 30-minute cycling sessions over 6-weeks, supervised by a physical therapist. MAIN OUTCOMES AND MEASURES: A priori feasibility criteria surrounding recruitment and enrolment rate, intervention adherence, technical difficulty, retention, and participant experience (acceptability, credibility, adverse events) were evaluated. Clinical outcomes (pain, function) and exercise capacity (perceptually regulated exercise test) were assessed at baseline, post-intervention, 1-month follow-up (clinical outcomes only). Within-session exercise engagement (work, time) and experience (perceived exertion, affect) were evaluated as process variables. RESULTS: All feasibility criteria were met. An average of 6.8 participants per week were eligible with a 73% enrollment rate. Participants attended 91% of intervention sessions, and 90% of participants completed follow-up assessments. VR technical issues were rare (3% of sessions) as were adverse events (2 unrelated to VR). Treatment acceptability and credibility was high and clinical outcomes improved in both groups. CONCLUSIONS: Progression to a full trial is supported due to high feasibility, acceptability, and improvement in clinical outcomes. RELEVANCE: Although not powered to evaluate efficacy, the within-group changes observed demonstrate that both cycling modalities can improve knee pain, function, and exercise capacity.