Proof-of-Concept of the SOAR (Stop OsteoARthritis) Program: A Randomized Delayed-Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Knee Extensor Strength over 9-weeks (knee injury participants)
研究概览
简要总结
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.
详细描述
Purpose:
The purpose of this study is to evaluate a novel, virtually delivered, PT-guided, knee health program (Stop OsteoARthritis - SOAR) for people who have been discharged from regular healthcare after a sports knee injury.
Objectives:
- The primary objective of the study is to assess the efficacy of an 8-week SOAR program to improve knee muscle strength measured by computerized dynamometry (primary outcome and daily average moderate to vigorous physical activity measured by Tri-axial Accelerometer (secondary outcome), self-reported knee-specific self-efficacy (secondary outcome), and self-reported knee-related quality of life (secondary outcome) in people discharged from regular care after sports knee trauma. Several exploratory outcomes will also be assessed to inform the design of a future clinical trial.
- A secondary objective of this study is to evaluate the feasibility of a protocol for a future full-scale clinical trial to assess the effectiveness and implementation of SOAR. Both SOAR program and study protocol implementation and practicality outcomes will be collected.
- A third objective of this study is to inform the optimal length of the SOAR program.
- A fourth, exploratory objective, of this study, is to explore the experiences of stakeholders (i.e., knee injury participants and physiotherapists) to inform future implementation.
Research Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Knee Injury Participant Inclusion Criteria:
- •16-35 years of age
- •Currently live in British Columbia, Canada
- •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
- •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.
- •Have daily access to an email address and a computer with internet
- •Are willing to wear an activity tracker during the study
- •Physiotherapist Participant Inclusion Criteria:
- •Registered physiotherapist
- •Able to communicate in English
- •Have an email address and daily access to a computer with internet service
排除标准
- •Knee Injury Participant Exclusion Criteria:
- •Inability to communicate in English
- •Previous physician diagnosis of index knee osteoarthritis
- •Inflammatory arthritis or systemic condition
- •Lower limb injury, surgery, or intra-articular injection in the past 6-months
- •Current pregnancy
- •Have a pacemaker or other internal medical device
- •Physiotherapist Participant Exclusion Criteria:
- •Do not hold a license to practice physiotherapy
- •Unable to communicate in English
- •Do not have an email address or daily access to a computer with internet service
研究组 & 干预措施
Immediate SOAR Program
Participants with a past sport-related knee injury randomized to the 'immediate intervention' group will complete an 8-week (weeks 1-8) SOAR program (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 physiotherapist counseling sessions, and optional weekly group-based exercise classes) followed by an additional 8 weeks (weeks 10-17) of home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT 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 immediate SOAR group knee injury participants.
干预措施: Immediate 8-Week SOAR Program (Behavioral)
Delayed SOAR Program
Participants with a past sport-related knee injury randomized to the 'delayed intervention' group will have a 9-week unstandardized delay before completing an 8-week SOAR program (weeks 10-17). During the delay (weeks 1-9) the delay comparison intervention will be unstandardized to reflect usual care in Canada. After the 9-week delay, these participants will complete an 8-week (weeks 10-17) SOAR program (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT counseling sessions, and an optional weekly group-based exercise classes). Consented trained physiotherapists will deliver the SOAR program from week 10 to week 17 to one or more delayed SOAR group knee injury participants.
干预措施: Delayed 8-Week SOAR Program (Behavioral)
结局指标
主要结局
Change in Knee Extensor Strength over 9-weeks (knee injury participants)
时间窗: Change from baseline knee extensor muscle strength at 9-weeks
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.
次要结局
- Change in Self-reported Knee-specific Self-Efficacy over 9-weeks (knee injury participants)(Change from baseline knee-specific self-efficacy at 9-weeks)
- Change in Self-reported Knee-related Quality of Life over 9-weeks (knee injury participants)(Change from baseline knee-related quality of life at 9-weeks)
- Change in Daily Average Moderate to Vigorous Physical Activity over 9-weeks (knee injury participants)(Change from baseline daily average moderate to vigorous physical activity at 9-weeks)
研究者
Jackie Whittaker
Assistant Professor
University of British Columbia