Osteoarthritis Clinical Trial
— SOARPOCOfficial title:
Proof-of-Concept of the SOAR (Stop OsteoARthritis) Program: A Randomized Delayed-Control Trial
Verified date | December 2023 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Adolescents and young adults who hurt their knees playing sports or doing recreational activities can develop joint damage, muscle weakness, inactivity, and weight gain which might lead to an increased risk of osteoarthritis (OA), a disabling joint condition in their later lives. Despite knowing that muscles and joints benefit from exercise, there is no proven exercise-based treatments to delay or even halt the onset of OA after a knee joint injury. The current study will assess if a physiotherapist-guided intervention called Stop OsteoARthritis (SOAR) improves knee muscle strength, physical inactivity, knee-related self-efficacy, and knee-related quality of life in people at risk for osteoarthritis due to a past knee injury. A total of 70 former knee injury participants will be randomly assigned to two groups. One group will immediately start a 16-week SOAR program, while the second will wait for 9-weeks before starting an 8-week SOAR program. Trained physiotherapists will deliver the SOAR program with videoconferencing. The study hypothesis is that participating in the 8-Week SOAR program will improve the knee muscle strength, physical activity levels, knee-related self-efficacy and knee-related quality of life in people discharged from regular healthcare after a sports knee injury. The findings will help researchers understand the ideal length of the program for a future clinical trial in real-world settings.
Status | Completed |
Enrollment | 58 |
Est. completion date | April 15, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 35 Years |
Eligibility | Inclusion Criteria: Knee Injury Participant Inclusion Criteria: 1. 16-35 years of age 2. Currently live in British Columbia, Canada 3. Experienced a sport-related intra-articular knee injury (i.e., clinical diagnosis of ligament, meniscal, or other intra-articular tibio- or patello-femoral trauma) that required both medical consultation (i.e., physician, physiotherapist, chiropractor, surgeon, or athletic therapist) and disrupted regular sports participation (missed at least one training session or competition) 12-36 months previously.18 4. Are currently not receiving ongoing health care related to the past knee injury and have no scheduled surgical procedures (any part of the body) that would interfere with exercise during the study. 5. Have daily access to an email address and a computer with internet 6. Are willing to wear an activity tracker during the study Physiotherapist Participant Inclusion Criteria: 1. Registered physiotherapist 2. Able to communicate in English 3. Have an email address and daily access to a computer with internet service Exclusion Criteria: Knee Injury Participant Exclusion Criteria: 1. Inability to communicate in English 2. Previous physician diagnosis of index knee osteoarthritis 3. Inflammatory arthritis or systemic condition 4. Lower limb injury, surgery, or intra-articular injection in the past 6-months 5. Current pregnancy 6. Have a pacemaker or other internal medical device Physiotherapist Participant Exclusion Criteria: 1. Do not hold a license to practice physiotherapy 2. Unable to communicate in English 3. Do not have an email address or daily access to a computer with internet service |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research, The Arthritis Society, Canada |
Canada,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Knee Extensor Strength over 18-weeks (knee injury participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate normalized peak concentric knee extension (quadriceps muscle) isokinetic torque (Nm/kg) at 90 degrees/seconds over 0-100 degrees of knee flexion. After a five-minute stationary cycling warm-up, participants will be seated with straps secured across their hips and chest. After three practice trials and a 30-second rest, participants will be instructed to bend and straighten their knee as hard and as fast as they can for three repetitions. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle strength. | Change from baseline knee extensor muscle strength at 18-weeks | |
Other | Change in Daily Average Moderate to Vigorous Physical Activity over 18-weeks (knee injury participants) | A small, lightweight hip worn wearable triaxial accelerometer (ActiGraph GT3X®) will be used to assess physical activity. Participants will be asked to wear this device (attached via an elastic belt around their waist), for a period of 7 consecutive days removing only for bathing/swimming activities. The average number of 10-minute moderate-to-vigorous physical activity bouts over the 7-day period will be calculated. Accelerometry is a valid measure of physical activity in youth and young adult populations. | Change from baseline daily average moderate to vigorous physical activity at 18-weeks | |
Other | Change in Self-reported Knee-specific Self-Efficacy over 18-weeks (knee injury participants) | A 19 item questionnaire (the Knee Self-efficacy Scale) will be used to measure self-reported knee-specific self-efficacy. Each item is scored on an 0-10-point Likert scale, with 0 indicating no knee-related self-efficacy and 10 indicating full knee-related self-efficacy. Individual item scores are summed and divided by 19 to produce a total score ranging from 0-10 (0 representing poor knee-related self-efficacy and 10 representing full knee-related self-efficacy). The total time for this questionnaire is 3 minutes. The Knee Self-efficacy Scale is a valid and reliable measure of knee-specific self-efficacy in individuals with a sport-related knee injury in the past five years. | Change from baseline knee-specific self-efficacy at 18-weeks | |
Other | Change in Self-reported Knee-related Quality of Life over 18-weeks (knee injury participants) | A 5 item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used to measure self-reported knee-related quality of life. Each item is scored on an 0-10-point Likert scale, with 0 indicating no knee-related quality of life and 10 indicating full knee-related quality of life. Individual item scores are summed and transformed to a score out of 100 (0 representing poor knee-related quality of life and 100 representing full knee-related quality of life). The total time for this questionnaire is 3 minutes. The KOOS knee-related quality of life sub-scale is a valid and reliable patient-reported outcome measure across multiple patient populations, including at various timepoints after knee trauma | Change from baseline knee-related quality of life at 18-weeks | |
Other | Change in Self-reported Knee-related Symptoms over 9-weeks (knee injury participants) | The 8 and 18 item symptom and pain subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used to measure self-reported knee-related symptoms. Each item is scored on an 0-10-point Likert scale, with 0 indicating a high degree of symptoms and 10 indicating no symptoms. Individual item scores are summed and transformed to a score between 0 and 100, with higher scores indicating a better outcome (i.e., fewer knee-related symptoms). The total time for this questionnaire is 3 minutes. The KOOS knee-related symptoms sub-scale is a valid and reliable patient-reported outcome measure across multiple patient populations, including at various timepoints after knee trauma. | Change from baseline knee-related symptoms at 9-weeks | |
Other | Change in Self-reported knee-related Sport and Recreation Function over 9-weeks (knee injury participants) | The 17 and 5 item function in daily living and function in sport and recreation subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used to measure self-reported knee-related symptoms. Each item is scored on an 0-10-point Likert scale, with 0 indicating no knee-related sport and recreation function and 10 indicating full knee-related sport and recreation function. Individual item scores are summed and transformed to a score out of 100 (0 representing poor knee-related sport and recreation function and 100 representing full knee-related sport and recreation function). The total time for this questionnaire is 3 minutes. The KOOS knee-related sport and recreation function sub-scale is a valid and reliable patient-reported outcome measure across multiple patient populations, including at various timepoints after knee trauma. | Change from baseline knee-related sport and recreation function at 9-weeks | |
Other | Change in Self-reported Overall Function over 9-weeks (knee injury participants) | The 3 item Patient Specific Functional Scale will be used to identify, quantify and assess changes in functional limitations that are most relevant to participants. This scale prompts participants to identify three activities important to them and rate their ability to perform each activity on a 10-point numerical rating scale. Individual scale scores are summed and transformed to a 0-100 scale with higher scores indicating better outcomes. The total time for this questionnaire is 3 minutes. The Patient-Specific Functional Scale is valid and reliable for use in persons with a knee injury. | Change from baseline self-reported overall function at 9-weeks | |
Other | Change in Self-reported Physical Activity over 9-weeks (knee injury participants) | The 4 item Godin Leisure Time Questionnaire will be used to measure self-reported physical activity. Using the number of 15-minute bouts of mild, moderate, and strenuous physical activity a participant engages in over a typical seven-day period weekly metabolic equivalents of physical activity are calculated. The total time for this questionnaire is 1 minute. The Godin Leisure Time Questionnaire has been validated to assess physical activity. | Change from baseline self-reported physical activity at 9-weeks | |
Other | Change in Self-reported Perceived Self-care over 9-weeks (knee injury participants) | The 12 item Partner in Health Scale will be used to measure perceived self-care (active involvement to self-manage a chronic condition). Each item is scored on a 0-9 point Likert scale. Scores on individual items are summed to produce a total score ranging between 0 and 96, with 0 representing no perceived self-management and 96 representing full perceived self-management. The total time for this questionnaire is 3 minutes. The Partner in Health Scale is valid and reliable across numerous chronic conditions. | Change from baseline self-reported perceived self-care at 9-weeks | |
Other | Change in Self-reported Fear of Movement and Re-injury over 9-weeks (knee injury participants) | The 11 item Tampa Scale of Kinesiophobia will be used to measure self-reported fear of movement and re-injury. Each item is scored on a 0-4 point Likert-scale, with 0 indicating no fear of movement and 4 indicating greater fear of movement. The item scores are summed to produce a total score ranging between 0 and 44, with higher values indicating a higher degree of fear of movement. The total time for this questionnaire is 3 minutes. The Tampa Scale of Kinesiophobia has evidence of known-group validity (scores discriminated between athletes who returned and did not return to pre-injury sports participation level after knee trauma). | Change from baseline self-reported fear of movement and re-injury at 9-weeks | |
Other | Change in Self-reported Perceived Social Support from family and friends over 9-weeks (knee injury participants) | The 12 item Multi-Dimensional Scale of Perceived Support will be used to measure perceived support from family, friends, and significant others. Each item is scored on a 0-7 point Likert scale, with 0 representing poor perceived support and 7 representing greater perceived support. Individual item scores are summed and divided by 12 to produce a total score ranging between 0 and 7 with higher scores indicating higher levels of perceived support. The total time for this questionnaire is 3 minutes. The Multi-Dimensional Scale of Perceived Support is reliable and valid across diverse general populations including adolescents. | Change from baseline self-reported perceived social support from family and friends at 9-weeks | |
Other | Change in Self-reported Perceived Social Support from Sport and Recreation Community over 9-weeks (knee injury participants) | The 16 item Perceived Available Social Support Questionnaire will be used to assess perceived support from the sporting or recreational community. Each item is scored on a 0-4 point Likert scale, with 0 representing poor perceived support and 4 representing greater perceived support. Individual item scores are summed and divided by 16 to produce a total score ranging from 0 to 4, with higher scores indicating higher levels of perceived support. The total time for this questionnaire is 3 minutes. The Perceived Available Social Support Questionnaire is a valid and reliable measure of self-reported perceived support for sporting populations. | Change from baseline self-reported perceived social support from the sport and recreation community 9-weeks | |
Other | Change in Knee Flexor Strength over 9-weeks (knee injury participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate normalized peak concentric knee flexor (hamstring muscles) isokinetic torque (Nm/kg) at 90 degrees/seconds over 0-100 degrees of knee flexion. After a five-minute stationary cycling warm-up, participants will be seated with straps secured across their hips and chest. After three practice trials and a 30-second rest, participants will be instructed to straighten and bend their knee as hard as they can for three repetitions. The total time for this test is 10 minutes (assessed in conjunction with normalized peak knee extension torque). Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle strength. | Change from baseline knee flexor muscle strength at 9-weeks | |
Other | Change in Knee Extension Power over 9-weeks (knee injury participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate knee extension power (Watts). After completing the protocol for normalized peak concentric knee extension and flexion torque the participants' knee joint will be fixed in 60 degrees of sagittal plane flexion. After three practice trials and a 30-second rest, participants will be instructed to straighten their knee as hard and as fast as they can for five seconds. This will be repeated five times with a 30-second rest period between each repetition. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle power. | Change from baseline knee extensor muscle power at 9-weeks | |
Other | Change in Knee Flexion Power over 9-weeks (knee injury participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate knee flexion power (Watts). After completing the protocol for normalized peak concentric knee extension and flexion torque the participants' knee joint will be fixed in 60 degrees of sagittal plane flexion. After three practice trials and a 30-second rest, participants will be instructed to bend their knee as hard and as fast as they can for five seconds. This will be repeated five times with a 30-second rest period between each repetition. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle power. | Change from baseline knee flexor muscle power at 9-weeks | |
Other | Change in Hop function over 9-weeks (knee injury participants) | Single leg hop function will be measured using the 6-meter timed hop test. Participants are asked to hop forward with the goal of covering a 6-meter distance as quickly as they can. Two practice trials will be completed on each limb, starting with the unaffected side to familiarize participants with the task. Participants will then complete two test trials on each limb, starting again with the unaffected side. The time (seconds) required to hop the 6-m distance will be recorded. This protocol will take 10 minutes. The 6-m timed hop is clinically applicable and reliable. | Change from baseline hop function at 9-weeks | |
Other | Change in Fat Mass Index over 9-weeks (knee injury participants) | Fat mass index (kg/m2) will be measured with Bioelectrical Impedance (Tanita Body Composition Analyzer, Model TBF-300A, Tanita Inc., USA). Participants will stand barefoot on the bioelectrical impedance platform during which the resistance to the flow of this single, high frequency alternating electrical current (500 A at 50 kHz) will be measured. Bioelectrical Impedance is a feasible method for assessing and tracking body composition in clinical settings and has been shown to be valid and reliable in child, youth, and adult populations. This test will take 5 minutes to complete. The device will be calibrated prior to each scan (according to the manufacturer's protocol). | Change in fat mass index over 9-weeks (knee injury participants) | |
Other | Perspectives of the intervention at 18-weeks (knee injury participants) | At the end of the study, semi-structured 1:1 interviews will be conducted with a sub-sample of 15-20 knee injury participants. Using an inductive approach and interview guide, participants will be asked open-ended queries about their experiences with the intervention (SOAR program). Interviews will last approximately 45 minutes. | Interviews will take place at 18-weeks | |
Other | Change in confidence to deliver the intervention over 18-weeks (physiotherapist participants) | A bespoke online survey will assess physiotherapists' overall confidence to deliver the intervention (SOAR program) including Brief Action Planning, SMART goal setting, and virtual physiotherapy delivery. Participants will be asked to rate their overall confidence on a 0-10 point numerical rating scale where 0 represents no confidence and 10 represents full confidence. The score will be transformed to a score between 0 and100, with higher scores indicating higher confidence. The survey will take 3 minutes to complete. | Change in confidence to deliver the intervention at 18-weeks | |
Primary | Change in Knee Extensor Strength over 9-weeks (knee injury participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate normalized peak concentric knee extension (quadriceps muscle) isokinetic torque (Nm/kg) at 90 degrees/seconds over 0-100 degrees of knee flexion. After a five-minute stationary cycling warm-up, participants will be seated with straps secured across their hips and chest. After three practice trials and a 30-second rest, participants will be instructed to straighten and bend their knee as hard as they can for three repetitions. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle strength. | Change from baseline knee extensor muscle strength at 9-weeks | |
Secondary | Change in Daily Average Moderate to Vigorous Physical Activity over 9-weeks (knee injury participants) | A small, lightweight hip worn wearable triaxial accelerometer (ActiGraph GT3X®) will be used to assess physical activity. Participants will be asked to wear this device (attached via an elastic belt around their waist), for a period of 7 consecutive days removing only for bathing/swimming activities. The average number of 10-minute moderate-to-vigorous physical activity bouts over the 7-day period will be calculated. Accelerometry is a valid measure of physical activity in youth and young adult populations. | Change from baseline daily average moderate to vigorous physical activity at 9-weeks | |
Secondary | Change in Self-reported Knee-specific Self-Efficacy over 9-weeks (knee injury participants) | A 19 item questionnaire (the Knee Self-efficacy Scale) will be used to measure self-reported knee-specific self-efficacy. Each item is scored on an 0-10-point Likert scale, with 0 indicating no knee-related self-efficacy and 10 indicating full knee-related self-efficacy. Individual item scores are summed and divided by 19 to produce a total score ranging from 0-10 (0 representing poor knee-related self-efficacy and 10 representing full knee-related self-efficacy). The total time for this questionnaire is 3 minutes. The Knee Self-efficacy Scale is a valid and reliable measure of knee-specific self-efficacy in individuals with a sport-related knee injury in the past five years. | Change from baseline knee-specific self-efficacy at 9-weeks | |
Secondary | Change in Self-reported Knee-related Quality of Life over 9-weeks (knee injury participants) | A 5 item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used to measure self-reported knee-related quality of life. Each item is scored on an 0-10-point Likert scale, with 0 indicating no knee-related quality of life and 10 indicating full knee-related quality of life. Individual item scores are summed and transformed to a score out of 100 (0 representing poor knee-related quality of life and 100 representing full knee-related quality of life). The total time for this questionnaire is 3 minutes. The KOOS knee-related quality of life sub-scale is a valid and reliable patient-reported outcome measure across multiple patient populations, including at various timepoints after knee trauma | Change from baseline knee-related quality of life at 9-weeks |
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