Study Summary
This trial will assess if a physiotherapist-guided intervention called Stop OsteoARthritis (SOAR) can help prevent osteoarthritis in people at risk due to a past knee injury.
Eligible Conditions
- Osteoarthritis of the Knee
- Arthritis
- Osteoarthritis
- Knee Arthritis
- Knee Injuries
- Anterior Cruciate Ligament (ACL) Tear
- Meniscus Tears
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Change from baseline hop function at 9-weeks
Change from baseline daily average moderate to vigorous physical activity at 18-weeks
Change in Daily Average Moderate to Vigorous Physical Activity over 18-weeks (knee injury participants)
Change from baseline daily average moderate to vigorous physical activity at 9-weeks
Change in Daily Average Moderate to Vigorous Physical Activity over 9-weeks (knee injury participants)
Change from baseline hop function at 9-weeks
Change in Hop function over 9-weeks (knee injury participants)
Change from baseline knee extensor muscle power at 9-weeks
Change in Knee Extension Power over 9-weeks (knee injury participants)
Change from baseline knee extensor muscle strength at 18-weeks
Change in Knee Extensor Strength over 18-weeks (knee injury participants)
Change from baseline knee extensor muscle strength at 9-weeks
Knee
Change from baseline knee flexor muscle power at 9-weeks
Change in Knee Flexion Power over 9-weeks (knee injury participants)
Change from baseline knee flexor muscle strength at 9-weeks
Knee
Change from baseline knee-related quality of life at 18-weeks
Change in Self-reported Knee-related Quality of Life over 18-weeks (knee injury participants)
Change from baseline knee-related quality of life at 9-weeks
Knee
Change from baseline knee-related sport and recreation function at 9-weeks
Change in Self-reported knee-related Sport and Recreation Function over 9-weeks (knee injury participants)
Change from baseline knee-related symptoms at 9-weeks
Change in Self-reported Knee-related Symptoms over 9-weeks (knee injury participants)
Change from baseline knee-specific self-efficacy at 18-weeks
Knee
Change from baseline knee-specific self-efficacy at 9-weeks
Change in Self-reported Knee-specific Self-Efficacy over 9-weeks (knee injury participants)
Change from baseline self-reported fear of movement and re-injury at 9-weeks
Change in Self-reported Fear of Movement and Re-injury over 9-weeks (knee injury participants)
Change from baseline self-reported overall function at 9-weeks
Knee
Change from baseline self-reported perceived self-care at 9-weeks
Change in Self-reported Perceived Self-care over 9-weeks (knee injury participants)
Change from baseline self-reported perceived social support from family and friends at 9-weeks
Change in Self-reported Perceived Social Support from family and friends over 9-weeks (knee injury participants)
Change from baseline self-reported perceived social support from the sport and recreation community 9-weeks
Change in Self-reported Perceived Social Support from Sport and Recreation Community over 9-weeks (knee injury participants)
Change from baseline self-reported physical activity at 9-weeks
Change in Self-reported Physical Activity over 9-weeks (knee injury participants)
Change in confidence to deliver the intervention at 18-weeks
Change in confidence to deliver the intervention over 18-weeks (physiotherapist participants)
Change in fat mass index over 9-weeks (knee injury participants)
Change in Fat Mass Index over 9-weeks (knee injury participants)
Interviews will take place at 18-weeks
Perspectives of the intervention at 18-weeks (knee injury participants)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Immediate SOAR Program
1 of 1
Experimental Treatment
70 Total Participants · 1 Treatment Group
Primary Treatment: Immediate 8-Week SOAR Program · No Placebo Group · N/A
Immediate SOAR Program
Behavioral
Experimental Group · 1 Intervention: Immediate 8-Week SOAR Program · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline hop function at 9-weeks
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,339 Previous Clinical Trials
1,553,244 Total Patients Enrolled
24 Trials studying Osteoarthritis
1,663 Patients Enrolled for Osteoarthritis
The Arthritis Society, CanadaOTHER
19 Previous Clinical Trials
4,334 Total Patients Enrolled
4 Trials studying Osteoarthritis
285 Patients Enrolled for Osteoarthritis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,248 Previous Clinical Trials
24,678,593 Total Patients Enrolled
18 Trials studying Osteoarthritis
1,519 Patients Enrolled for Osteoarthritis
Michael Smith Foundation for Health ResearchOTHER
17 Previous Clinical Trials
6,175 Total Patients Enrolled
1 Trials studying Osteoarthritis
135 Patients Enrolled for Osteoarthritis
Jackie L Whittaker, PhD, PTPrincipal InvestigatorUniversity of British Columbia
Eligibility Criteria
Age 16 - 35 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be between 16 and 35 years old.
You are not currently receiving medical treatment or scheduled for surgery that may affect your ability to participate in the study exercises, specifically related to past knee injuries.
You need to have access to a computer with internet and an email account that you use every day.
You currently reside in British Columbia, Canada.
You agree to wear a device that tracks your activity throughout the study.
You had a knee injury while playing sports that required medical attention and prevented you from participating in sports for at least one training session or competition in the past 12-36 months.
You are a physiotherapist who is officially recognized and licensed.
You have an email address and can use a computer with internet every day.
Who else is applying?
What state do they live in?
| Florida | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Frequently Asked Questions
Who is eligible to participate in this experimental trial?
"This clinical study is seeking 70 participants aged 16-35 who have recently experienced knee injuries. In order to be eligible, candidates must live in British Columbia, Canada and meet the following prerequisites: possess a registered physiotherapist; access to an email address and computer with internet connection on a daily basis; willingness to wear activity tracker during trial period; medical consultation for injury plus disrupted regular sports participation (missed at least one training session or competition) 12-36 months ago; no ongoing health care related to past knee trauma nor planned surgical procedures which could interfere with exercise while enrolled." - Anonymous Online Contributor
Unverified Answer
Are new participants accepted into this experiment?
"Affirmative. Clinicaltrials.gov data demonstrates that this clinical trial, which went online on September 1st 2021, is actively searching for participants. Approximately 70 individuals must be enrolled from a single medical centre." - Anonymous Online Contributor
Unverified Answer
Is eligibility for participation in this clinical trial restricted to persons of a certain age?
"Individuals between the ages of 16 and 35 are welcome to enroll in this research study." - Anonymous Online Contributor
Unverified Answer
What is the total sample size of this medical study?
"Affirmative. According to clinicaltrials.gov, this research project was first posted on September 1st 2021 and is still looking for participants with the most recent update being made on September 30th 2021. The trial requires 70 volunteers from a single medical facility." - Anonymous Online Contributor
Unverified Answer