MULTIple or ONE home strengthening exercise(s) for knee osteoarthritis: Protocol for the MULTI-ONE randomised controlled trial

Objective: To determine the effectiveness of a prescribed home exercise program comprised of a single strengthening exercise compared to i) a program with multiple (five) strengthening exercises and ii) control (usual care) for reducing walking pain in people with knee osteoarthritis (OA). Design: A multi-centre superiority randomised controlled trial will be conducted, involving 144 people with chronic knee pain consistent with OA. Participants will be randomised to receive i) control (usual care); ii) a prescribed home program with one strengthening exercise or; iii) a prescribed home program with multiple (five) strengthening exercises. Participants in the exercise groups will have three consultations over 3 months with a physiotherapist for prescription, monitoring and progression of their exercise program, which will be performed independently at home. The primary outcome measure will be change in walking pain measured on a numerical rating scale. Secondary outcomes will include WOMAC pain and function subscales, quality-of-life; arthritis and exercise self-efficacy; fear of movement; global rating of change; muscle strength/power; and willingness for joint replacement. Primary time-point for re-assessment will be 3 months, with a secondary time-point of 9 months, after randomisation. Ethics and dissemination: This trial is approved by the University of Melbourne Human Research Ethics Committee (#29890). Dissemination will occur via lay summaries, infographics, conference abstracts, oral presentations and journal papers. Clinical trial registration: Australian New Zealand Clinical Trials Registry ACTRN12624001226594. Prospectively registered on 9/10/2024. Conclusions: Findings will guide clinicians in choosing how many home strengthening exercises to prescribe for people with knee OA.