Stopping OsteoARthritis After an ACL Tear

NCT06195423 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

  • Knee Injuries
  • Anterior Cruciate Ligament Rupture
  • Osteoarthritis, Knee

Interventions

BEHAVIORAL

Stop OsteoARthritis (SOAR) program

The SOAR program is a 6-month, online-delivered (videoconferencing), PT-guided knee health program which consists of; 1. Knee Camp: Includes interactive education, and 1:1 physiotherapy knee exam and counseling session to co-identify home-based exercise-therapy and physical activity goals to address participants' unique functional limitations. Participants are given a wrist-worn activity monitor to wear 24hours/day. 2. Individualized Weekly Home-based Exercise-Therapy and Physical Activity Program: At home, participants work to meet their exercise-therapy and physical activity goals. Exercises and physical activity are tracked with an online form and the activity monitor. Participants can also attend an optional weekly group class. 3. Weekly PT-guided Exercise-Therapy and Physical Activity Counselling: Each week, participants attend a 1:1 physiotherapist counseling session to modify exercise-therapy and physical activity goals.

BEHAVIORAL

Living Well after ACLR program

Participants in the minimal intervention CONTROL group will receive access to a 30-minute educational video (knee anatomy, ACLR information, general exercise, physical activity, and goal-setting principles), a best practice workbook, one video-recorded virtual session with a physiotherapist (naïve to SOAR) who will explain the booklet and answer questions but not volunteer information beyond the video or booklet and the same wrist-worn activity tracker as the experimental group.

Sponsors & Collaborators

  • Arthritis Research Centre of Canada

    collaborator OTHER
  • The Arthritis Society, Canada

    collaborator OTHER
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jackie L Whittaker, BScPT, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-12-30
Completion
2028-12-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06195423 on ClinicalTrials.gov