CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Immediate 8-Week SOAR Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04956393
NCT04956393N/ACompleted

Proof-of-Concept of the SOAR (Stop OsteoARthritis) Program: A Randomized Delayed-Control Trial

University of British Columbia·interventional·Posted Jul 9, 2021·Updated Dec 26, 2023

In Brief

A clinical study evaluating Immediate 8-Week SOAR Program and Delayed 8-Week SOAR Program for Arthritis and 6 related conditions. Completed, enrolled 58 participants across 1 site.

Detailed Summary

Adolescents and young adults who hurt their knees playing sports or doing recreational activities can develop joint damage, muscle weakness, inactivity, and weight gain which might lead to an increased risk of osteoarthritis (OA), a disabling joint condition in their later lives. Despite knowing that muscles and joints benefit from exercise, there is no proven exercise-based treatments to delay or even halt the onset of OA after a knee joint injury. The current study will assess if a physiotherapist-guided intervention called Stop OsteoARthritis (SOAR) improves knee muscle strength, physical inactivity, knee-related self-efficacy, and knee-related quality of life in people at risk for osteoarthritis due to a past knee injury. A total of 70 former knee injury participants will be randomly assigned to two groups. One group will immediately start a 16-week SOAR program, while the second will wait for 9-weeks before starting an 8-week SOAR program. Trained physiotherapists will deliver the SOAR program with videoconferencing. The study hypothesis is that participating in the 8-Week SOAR program will improve the knee muscle strength, physical activity levels, knee-related self-efficacy and knee-related quality of life in people discharged from regular healthcare after a sports knee injury. The findings will help researchers understand the ideal length of the program for a future clinical trial in real-world settings.

Study Details

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 9, 2021
Enrollment StartSep 1, 2021
Primary CompletionFeb 28, 2023
Study CompletionApr 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.0 years ago

Interventions

Immediate 8-Week SOAR Programbehavioral

This is an 8-week, virtually delivered, exercise-based, knee health program delivered to knee injury participants by trained physiotherapists. The program has 3 components: 1. Knee Camp: This includes an interactive education session about knee health, 1:1 knee exam, and 1:1 counseling session to identify Specific, Measurable, Attainable, Relevant, and Time-bound (SMART) weekly home-based exercise-therapy and physical activity goals, Participants are asked to wear Fitbit's® 24-hours/day. 2. Weekly Home-based Exercise-Therapy and Physical Activity, with Tracking: At home, participants work to meet their exercise-therapy and physical activity goals. Exercises are tracked with an online bespoke form and activity, with a Fitbit. 3. Weekly PT-guided Exercise-Therapy and Physical Activity Counseling Sessions: Each week participants will attend a 1:1 virtual physiotherapist counseling session to modify SMART goals and have the option to attend a group exercise class.

Delayed 8-Week SOAR Programbehavioral

This is an 8-week, virtually delivered, exercise-based, knee health program delivered to knee injury participants by trained physiotherapists. The program has 3 components: 1. Knee Camp: This includes an interactive education session about knee health, 1:1 knee exam, and 1:1 counseling session to identify Specific, Measurable, Attainable, Relevant, and Time-bound (SMART) weekly home-based exercise-therapy and physical activity goals, Participants are asked to wear Fitbit's® 24-hours/day. 2. Weekly Home-based Exercise-Therapy and Physical Activity, with Tracking: At home, participants work to meet their exercise-therapy and physical activity goals. Exercises are tracked with an online bespoke form and activity, with a Fitbit. 3. Weekly PT-guided Exercise-Therapy and Physical Activity Counseling Sessions: Each week participants will attend a 1:1 virtual physiotherapist counseling session to modify SMART goals and have the option to attend a group exercise class.