Comparing Stop OsteoARthritis (SOAR) program with Living Well after ACLR program for knee injuries
Official title: Stopping OsteoARthritis After an ACL Tear
The Stop Osteoarthritis (SOAR) Hybrid Effectiveness-Implementation Type 1 Randomized Controlled Trial for Young People At-High-Risk of Early Onset Knee Osteoarthritis
- 2 groups
- Sites in Vancouver and Whistler
- Recruiting
Interventions
- Behavioural therapy
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.
- Behavioural therapy
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.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Arthritis Research Canada
Vancouver, British Columbia
- Recruiting
Sea to Sky Orthopaedics
Whistler, British Columbia
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +16-35 years of age (inclusive)
- +9-36-months past a first-time ACLR performed ≤12-months of first-time ACL tear
- +Currently live in British Columbia, Canada
- +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
Exclusion
- −Inability to communicate in English
- −No medical attention (healthcare provider) time-loss (missed physical activity, sport or work ≥2 occasions) injury to the ACLR knee before the ACL tear
- −Previous physician diagnosis of index knee osteoarthritis
- −Inflammatory arthritis or other systemic condition
- −Current pregnancy
- −Lower limb injury, surgery, or intra-articular injection in the past 6-months
- −MRI contraindications (i.e., Weight over 400 lbs (MRI machine limit); Pacemaker or any other implanted medical device (i.e., wires, defibrillator, artificial heart valve, an electronic device like a drug infusion pump, electrical stimulator for nerves or bones, coil, catheter, or filter in any blood vessel, ear or eye implant, or stainless steel intrauterine device (IUD); Brain or ferromagnetic aneurysm clip; any other metallic prostheses or shrapnel, bullets, or other metal fragments; injury where a piece of metal lodged in the eye or orbit, or; surgery, medical procedure or tattoos (including tattooed eyeliner) in the last 6 weeks).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Stop OsteoARthritis (SOAR) program.
Registry label: A: Stop OsteoARthritis (SOAR) program
Group B, the comparison group, receives Living Well after ACLR program.
Registry label: B: Living Well after ACLR
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 16 years to 35 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 210 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → KOOS score at 6 months (ACL tear participants).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (ACL tear participants) — measured over Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → KOOS score at 6 months (ACL tear participants).
Incremental cost-utility ratio over 6 months (efficiency outcome) — measured over Incremental cost-utility ratio at 6 months.
Provider adoption of SOAR over 6 months (implementation outcome) (physiotherapist participants) — measured over Percent fidelity at 6 months (physiotherapist participants).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06195423 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Stop OsteoARthritis (SOAR) programBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About Living Well after ACLR programBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 16 years to 35 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 16 years to 35 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → KOOS score at 6 months (ACL tear participants).
The study as a whole is currently expected to finish around 2028-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 210 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Vancouver, British Columbia, Canada; Whistler, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.