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. 2025 Jun 20;26(1):213.
doi: 10.1186/s13063-025-08896-6.

Digital education and exercise therapy versus minimal intervention for young people at high risk of early onset knee osteoarthritis after ACL reconstruction: a study protocol for the Stop OsteoARthritis (SOAR) randomized controlled trial

Jackie L Whittaker  1   2   3 , Amanda Cammalleri  4   5 , Candice Archibald  6 , Alexandra Brooks-Hill  7   8 , Patrick Chin  7   9 , Sarah Clark  7   8 , Jennifer C Davis  10   11 , Alison M Hoens  4   5 , Michael A Hunt  4   10 , Karin Kausky  12 , Angelina Ko  13 , Lise Leveille  7   14 , Linda C Li  4   5   10 , Parth Lodhia  7   15 , Justin M Losciale  16 , Maxi Miciak  17 , Amber D Mosewich  18 , Adnan Sheikh  19 , Trish Silvester-Lee  5 , Linda K Truong  4   10 , Dominic Wade  20 , David R Wilson  10   7   21 , Hui Xie  5   22 , Xian He Yan  4   5   10 , Ewa M Roos  23
Affiliations

Digital education and exercise therapy versus minimal intervention for young people at high risk of early onset knee osteoarthritis after ACL reconstruction: a study protocol for the Stop OsteoARthritis (SOAR) randomized controlled trial

Jackie L Whittaker et al. Trials. .

Abstract

Background: People who tear their anterior cruciate ligament and have reconstruction surgery (ACLR) are at elevated risk of inactivity, obesity, and early-onset knee osteoarthritis. Consensus recommendations to prevent post-traumatic knee osteoarthritis include person-centered education and exercise-based treatments. The effectiveness of these recommendations is unknown. This study will assess if a digital education and exercise therapy intervention is superior to minimal intervention for improving knee-related symptoms, function, and quality of life in young people after ACLR.

Methods: The Stop OsteoARthritis (SOAR) study is a parallel, two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 randomized controlled trial. After baseline testing, 166 participants aged 16-35 years, 9-36 months past, a first-time ACLR with ongoing symptoms will be randomly allocated to one of two treatment groups (1:1 ratio, stratified by sex). Ongoing symptoms will be defined as not meeting a Patient Acceptable Symptom State (PASS) on the averaged Knee injury and Osteoarthritis Outcome Score pain, symptoms function in sport and recreation, and quality-of-life subscales (KOOS4 < 79). Participants randomized to the experimental intervention will receive a digital (remote videoconferencing) 6-month program of group-based learning, individualized weekly home-based exercise therapy and physical activity program with tracking, and 1:1 physiotherapist-guided counseling. Participants randomized to the minimal intervention control group will receive an educational recording, best-practice guide for ACLR rehabilitation, one videoconferencing session, and tracking. The primary effectiveness outcome is the between-group difference in KOOS4 change from baseline to 6-months, with secondary endpoints at 12- and 24months. Secondary effectiveness outcomes include differences in the change of individual KOOS subscale scores, proportions of participants achieving KOOS subscale PASS scores, perceived self-management, and MRI features of knee OA. We will also assess secondary implementation (perceived barriers and facilitators of SOAR delivery), secondary efficiency (incremental cost-utility ratio), and exploratory outcomes. Missing data will be imputed and blinded intention-to-treat analyses performed.

Discussion: By assessing the effect, implementation, and efficiency of a digital education and exercise-based intervention designed to improve the knee health of young people at increased risk of knee osteoarthritis, this study will provide a basis for future scale-up to help curb the mounting burden of osteoarthritis.

Trial registration: ClinicalTrials.gov NCT06195423. Registered on December 22, 2023.

Keywords: Action planning; Education; Exercise therapy; Goal-setting; Physical therapy; Post-traumatic osteoarthritis; Prevention; Self-management; Telerehabilitation.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate {24}: Ethical approval has been obtained from the University of British Columbia Clinical Research Ethics Board (CREB) on March 5, 2024 (REB #H23-03544) and all participants will provide informed consent. UBC CREB Contact Pia Ganz, CREB Manager (oversees the functioning of the CREB staff and Board, monitors ethical review process standards, and advises on compliance with ethics policies) pia.ganz@ubc.ca, Room 210, Research Pavilion, 828 West 10 th Avenue, Vancouver, BC, Canada V5Z 1M9. Consent for publication {32}: There is no pilot or baseline data or images of videos relating to an individual person in this study protocol. Competing interests {28}: JLW is supported by a Michael Smith Health Research British Columbia Scholar Award (SCH-2020–0403) and is a Senior Editor with the Journal of Orthopaedic and Sport Physical Therapy, associate editor with the British Journal of Sports Medicine, Arthritis Society (Canada) Integrated Scientific and Medical Advisory Committee member, and Data Safety and Monitoring Committee member for the PIKASO trial. JML is an associate editor of the Journal of Orthopaedic and Sports Physical Therapy. XHY is supported by the Faculty of Medicine Graduate Award (UBC). MM has received an honorarium from the Institute of Musculoskeletal Health and Arthritis, Canadian Institutes of Health Research. JCD is a Canada Research Chair (Tier 2) in Applied Health Economics and Michale Smith Health Research BC Scholar. The remaining authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Participant flow chart
See this image and copyright information in PMC

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