Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial.

Background: Knee trauma permanently elevates one's risk for knee osteoarthritis. Despite this, people at-risk of post-traumatic knee osteoarthritis rarely seek or receive care, and accessible and efficacious interventions to promote knee health after injury are lacking. Exercise can ameliorate some mechanisms and independent risk factors for osteoarthritis and, education and action-planning improve adherence to exercise and promote healthy behaviours.

Methods: To assess the efficacy of a virtually-delivered, physiotherapist-guided exercise-based program (SOAR) to improve knee health in persons discharged from care after an activity-related knee injury, 70 people (16-35 years of age, 12-48 months post-injury) in Vancouver Canada will be recruited for a two-arm step-wedged assessor-blinded delayed-control randomized trial. Participants will be randomly allocated to receive the intervention immediately or after a 10-week delay. The program consists of 1) one-time Knee Camp (group education, 1:1 individualized exercise and activity goal-setting); 2) weekly individualized home-based exercise and activity program with tracking, and; 3) weekly 1:1 physiotherapy-guided action-planning with optional group exercise class. Outcomes will be measured at baseline, 9- (primary endpoint), and 18-weeks. The primary outcome is 9-week change in knee extension strength (normalized peak concentric torque; isokinetic dynamometer). Secondary outcomes include 9-week change in moderate-to-vigorous physical activity (accelerometer) and self-reported knee-related quality-of-life (Knee injury and OA Outcome Score subscale) and self-efficacy (Knee Self Efficacy Scale). Exploratory outcomes include 18-week change in primary and secondary outcomes, and 9- and 18- week change in other components of knee extensor and flexor muscle function, hop function, and self-reported symptoms, function, physical activity, social support, perceived self-care and kinesiophobia. Secondary study objectives will assess the feasibility of a future hybrid effectiveness-implementation trial protocol, determine the optimal intervention length, and explore stakeholder experiences.

Discussion: This study will assess the efficacy of a novel, virtually-delivered, physiotherapist-guided exercise-based program to optimize knee health in persons at increased risk of osteoarthritis due to a past knee injury. Findings will provide valuable information to inform the management of osteoarthritis risk after knee trauma and the conduct of a future effectiveness-implementation trial.

Trial Registration: Clinicaltrials.gov reference: NTC04956393. Registered August 5, 2021, https://clinicaltrials.gov/ct2/show/NCT04956393?term=SOAR&cond=osteoarthritis&cntry=CA&city=Vancouver&draw=2&rank=1.