The Stop Osteoarthritis (SOAR) Hybrid Effectiveness-Implementation Type 1 Randomized Controlled Trial for Young People At-High-Risk of Early Onset Knee Osteoarthritis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

By 2040, 25% of Canadians will have osteoarthritis, a disabling joint condition. Most people think osteoarthritis only affects older adults, but 50% of the 700,000 Canadian youth who hurt their knee playing sports annually will develop osteoarthritis by 40 years of age. These young people with old knees face knee pain and disability for much of their adult lives, interfering with parenting, work, and recreation. Yet, most do not know about osteoarthritis or how to reduce their risk. In this clinical trial, people who have torn the Anterior Cruciate ligament in their knee and had reconstruction surgery 9-36 months previously will be randomized to receive either a 6-month virtual education and exercise therapy program called Stop OsteoARthritis (SOAR) or a minimal intervention control program. Researchers will test if those who received the SOAR program have larger gains in knee health, including pain, symptoms, function, and quality of life at 6, 12, and 24 months. Researchers will also use MRIs (baseline and 24 months) to assess how the SOAR program influences knee cartilage degeneration and its cost-effectiveness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 35
Healthy Volunteers: f
View:

• Currently live in British Columbia, Canada

• 16-35 years of age (inclusive)

• 9-36-months past a first-time ACLR performed ≤12-months of first-time ACL tear

• Currently not receiving knee care from a health or fitness provider and have no scheduled surgical procedures (any part of the body) that would interfere with exercise during the study.

• Score below a KOOS4 PASS (\<79 points)

• Have daily access to an email address and a computer with internet

• Are willing to wear an activity tracker during the study

Locations
Other Locations
Canada
Arthritis Research Canada
RECRUITING
Vancouver
Sea to Sky Orthopaedics
RECRUITING
Whistler
Contact Information
Primary
Jackie L Whittaker, BScPT, PhD
jackie.whittaker@ubc.ca
604-202-1362
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 210
Treatments
Experimental: Stop OsteoARthritis (SOAR) program
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.
Active_comparator: Living Well after ACLR
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).
Related Therapeutic Areas
Sponsors
Collaborators: Arthritis Research Centre of Canada, The Arthritis Society, Canada
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov