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Behavioural Intervention
SOAR Program for Preventing Osteoarthritis After ACL Tear (SOAR Trial)
N/A
Recruiting
Led By Jackie L Whittaker, BScPT, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
16-35 years of age (inclusive)
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1:1 interviews will be conducted at 6 months (acl tear participants)
Awards & highlights
Summary
This trial aims to help young people who have torn their knee ligament and undergone surgery. Participants will either receive a 6-month virtual education and exercise program or a minimal intervention. The study will assess
Who is the study for?
This trial is for young adults aged 16-35 in British Columbia who had ACL reconstruction surgery 9-36 months ago. Participants should not be currently receiving other knee treatments, have limited knee function as measured by a KOOS4 score, and must have daily internet access to participate in virtual programs.
What is being tested?
The study compares the SOAR program—a virtual education and exercise therapy—with a minimal intervention control program for improving knee health post-ACL tear. It measures pain relief, symptom improvement, better function, quality of life over time, and uses MRIs to check cartilage changes.
What are the potential side effects?
Since this trial involves educational material and exercise therapy rather than medication or invasive procedures, significant side effects are not expected. However, participants may experience typical exercise-related discomfort or injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 16 and 35 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1:1 interviews will be conducted at 6 months (acl tear participants)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1:1 interviews will be conducted at 6 months (acl tear participants)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incremental cost-utility ratio over 6 months (efficiency outcome)
Provider adoption of SOAR over 6 months (implementation outcome) (physiotherapist participants)
Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (ACL tear participants)
Secondary outcome measures
Features of PT counselling that promote self-management over 6 months (ACL tear participants)
Health resource use costs over 24 months
Intervention delivery costs over 6 months
+5 moreOther outcome measures
Change in Daily Average Moderate to Vigorous Physical Activity over 12 months (ACL tear participants)
Change in Daily Average Moderate to Vigorous Physical Activity over 24 months (ACL tear participants)
Change in Daily Average Moderate to Vigorous Physical Activity over 6 months (ACL tear participants)
+33 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stop OsteoARthritis (SOAR) programExperimental Treatment1 Intervention
Participants with a first-time ACL tear followed by reconstruction surgery randomized to the SOAR program group will complete a 6-month SOAR program (one-time Knee Camp, weekly home-based exercise therapy and physical activity with tracking, weekly 1:1 physiotherapist counseling sessions, and optional weekly group-based exercise classes) Consented trained physiotherapists will deliver the SOAR program throughout the study period to one or more SOAR program participants. Physiotherapists and SOAR participants will be randomly paired.
Group II: Living Well after ACLRActive Control1 Intervention
Participants with a first-time ACL tear followed by reconstruction surgery randomized to the minimal control (Living Well after ACLR) group will complete a 6-month minimal intervention control program (educational video, workbook, activity tracking, and one 1:1 physiotherapist counseling session).
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,482,980 Total Patients Enrolled
Arthritis Research Centre of CanadaOTHER
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13,608 Total Patients Enrolled
The Arthritis Society, CanadaOTHER
25 Previous Clinical Trials
9,511 Total Patients Enrolled
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