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
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...
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2025-06-01
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| Online Access: | https://doi.org/10.1186/s13063-025-08896-6 |
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| author | Jackie L. Whittaker Amanda Cammalleri Candice Archibald Alexandra Brooks-Hill Patrick Chin Sarah Clark Jennifer C. Davis Alison M. Hoens Michael A. Hunt Karin Kausky Angelina Ko Lise Leveille Linda C. Li Parth Lodhia Justin M. Losciale Maxi Miciak Amber D. Mosewich Adnan Sheikh Trish Silvester-Lee Linda K. Truong Dominic Wade David R. Wilson Hui Xie Xian He Yan Ewa M. Roos |
| author_facet | Jackie L. Whittaker Amanda Cammalleri Candice Archibald Alexandra Brooks-Hill Patrick Chin Sarah Clark Jennifer C. Davis Alison M. Hoens Michael A. Hunt Karin Kausky Angelina Ko Lise Leveille Linda C. Li Parth Lodhia Justin M. Losciale Maxi Miciak Amber D. Mosewich Adnan Sheikh Trish Silvester-Lee Linda K. Truong Dominic Wade David R. Wilson Hui Xie Xian He Yan Ewa M. Roos |
| author_sort | Jackie L. Whittaker |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3ee126661a8a4df88eb4abc9e5bf5e9d |
| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj-art-3ee126661a8a4df88eb4abc9e5bf5e9d2025-08-20T03:22:54ZengBMCTrials1745-62152025-06-0126112110.1186/s13063-025-08896-6Digital 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 trialJackie L. Whittaker0Amanda Cammalleri1Candice Archibald2Alexandra Brooks-Hill3Patrick Chin4Sarah Clark5Jennifer C. Davis6Alison M. Hoens7Michael A. Hunt8Karin Kausky9Angelina Ko10Lise Leveille11Linda C. Li12Parth Lodhia13Justin M. Losciale14Maxi Miciak15Amber D. Mosewich16Adnan Sheikh17Trish Silvester-Lee18Linda K. Truong19Dominic Wade20David R. Wilson21Hui Xie22Xian He Yan23Ewa M. Roos24Department of Physical Therapy, Faculty of Medicine, University of British ColumbiaDepartment of Physical Therapy, Faculty of Medicine, University of British ColumbiaKootenay Therapy CenterDepartment of Orthopaedics, Faculty of Medicine, University of British ColumbiaDepartment of Orthopaedics, Faculty of Medicine, University of British ColumbiaDepartment of Orthopaedics, Faculty of Medicine, University of British ColumbiaCentre for Aging SMART, University of British ColumbiaDepartment of Physical Therapy, Faculty of Medicine, University of British ColumbiaDepartment of Physical Therapy, Faculty of Medicine, University of British ColumbiaWhistler 360Do Well TherapyDepartment of Orthopaedics, Faculty of Medicine, University of British ColumbiaDepartment of Physical Therapy, Faculty of Medicine, University of British ColumbiaDepartment of Orthopaedics, Faculty of Medicine, University of British ColumbiaInformatice, Decision-Enhancement and Analytic Science Centre of Innovation, George E. Whalen Veteran Affairs Medical CentreFaculty of Rehabilitation Medicine, University of AlbertaFaculty of Kinesiology, Sport, and Recreation, University of AlbertaDepartment of Radiology, Faculty of Medicine, University of British ColumbiaArthritis Research CanadaDepartment of Physical Therapy, Faculty of Medicine, University of British ColumbiaNexus RehabilitationCentre for Aging SMART, University of British ColumbiaArthritis Research CanadaDepartment of Physical Therapy, Faculty of Medicine, University of British ColumbiaDepartment of Musculoskeletal Function and Physiotherapy, University of Southern DenmarkAbstract 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.https://doi.org/10.1186/s13063-025-08896-6Action planningEducationExercise therapyGoal-settingPhysical therapyPrevention |
| spellingShingle | Jackie L. Whittaker Amanda Cammalleri Candice Archibald Alexandra Brooks-Hill Patrick Chin Sarah Clark Jennifer C. Davis Alison M. Hoens Michael A. Hunt Karin Kausky Angelina Ko Lise Leveille Linda C. Li Parth Lodhia Justin M. Losciale Maxi Miciak Amber D. Mosewich Adnan Sheikh Trish Silvester-Lee Linda K. Truong Dominic Wade David R. Wilson Hui Xie Xian He Yan Ewa M. Roos 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 Trials Action planning Education Exercise therapy Goal-setting Physical therapy Prevention |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Action planning Education Exercise therapy Goal-setting Physical therapy Prevention |
| url | https://doi.org/10.1186/s13063-025-08896-6 |
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