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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

No Placebo-Only Group

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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1:1 interviews will be conducted at 6 months (acl tear participants) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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).

0 / 1Eligibility criteria met