Preventing Post-traumatic Osteoarthritis and Other Health Consequences Following Knee Joint Injury: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Participation Rate
研究概览
简要总结
This study evaluates the preliminary efficacy of an 8-week exercise and education intervention on musculoskeletal health of young adults with a previous sport-related knee injury that are at high risk of post-traumatic osteoarthritis. In addition, the purpose of this pilot randomized controlled trial is to determine the feasibility of the study methods and procedures to inform the design of a future randomized controlled trial.
详细描述
PURPOSE
The purpose of this study is to determine the preliminary efficacy of an 8-week exercise and education intervention on musculoskeletal health of young adults with a previous sport-related knee injury that are at high risk of post-traumatic osteoarthritis. In addition, the purpose is to determine the feasibility of the study methods and procedures. In addition, the longitudinal changes in health-related factors in participants who are recruited from a previous cohort study will be described, as well as the estimated cost of healthcare utilization during one year in a population of young adults with history of sport-related knee injury.
METHODS
Study design and participants
This is a pilot randomized controlled trial stepped-wedge design. Participants will include 40 men and women, age 21 to 33 years, who sustained a physician-confirmed youth (≤ 18 years of age) sport-related intra-articular knee injury 5 to 16 years ago.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research assistants performing testing and data entry and the investigators performing analysis will be blinded throughout the study.
入排标准
- 年龄范围
- 21 Years 至 33 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained a physician-confirmed intra-articular sport-related knee injury in age 18 years or younger
排除标准
- •Injury or a flare-up at the time of recruitment, which makes the individual unable to participate in more than two exercises in the exercise program
- •Pregnancy
- •Any contraindication to exercise
- •Lower extremity surgery within the last 6 months
- •Already attending structured supervised exercise or other treatment to improve knee function
- •Not available to participate in the weekly exercise classes
结局指标
主要结局
Participation Rate
时间窗: Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.
Attendance in the group exercise classes and completion of the home exercise sessions will be recorded. Participation rate for the two study groups (intervention/control) will be calculated as the proportion of completed group exercise classes and home exercise sessions out of the total possible group exercise classes and home exercise sessions over the 8-week intervention.
Knee Extension Strength
时间窗: Baseline, 8-weeks, 16-weeks and 24-weeks
Normalized knee extension strength will be assessed using hand-held isometric dynamometry. The peak isometric strength (N) from the three trials will be recorded for both legs. The peak isometric strength scores are converted to torque values (Nm; force x distance between joint line and dynamometer position) and normalized to body weight (Nm/kg). The mean value of the three trials will be calculated.
次要结局
- Time at Heart Rate Zone of 81 to 90 percent of HRmax(Each supervised group exercise class (twice a week for 8 weeks))
- Measured Exercise Fidelity(Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.)
- Hip Abduction Strength(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Retention Rate(The duration of the study (weeks 1-24), will be calculated in the end.)
- Major and Minor Adverse Events(The duration of the study (weeks 1-24))
- Maximum Heart Rate(Each supervised group exercise class (twice a week for 8 weeks))
- Time at Heart Rate Zone of 50 to 60 percent of HRmax(Each supervised group exercise class (twice a week for 8 weeks))
- Intermittent and Constant Osteoarthritis Pain (ICOAP)(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Observed Exercise Fidelity(Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.)
- Time at Heart Rate Zone of 71 to 80 percent of HRmax(Each supervised group exercise class (twice a week for 8 weeks))
- Time at Heart Rate Zone of >90 percent of HRmax(Each supervised group exercise class (twice a week for 8 weeks))
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Joint-Specific Adverse Events(The duration of the study (weeks 1-24))
- Self-reported Pain Before and After Exercise(Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.)
- Time at Heart Rate Zone of 61 to 70 percent of HRmax(Each supervised group exercise class (twice a week for 8 weeks))
- Health-related Quality of Life (EQ-5D-5L)(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Program Progression Achieved(Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.)
- Average Heart Rate(Each supervised group exercise class (twice a week for 8 weeks))
- Tampa Scale for Kinesiophobia (TSK)(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Knee Flexion Strength(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Hip Adduction Strength(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Triple Single-Leg Hop(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Single-Leg Hop for Distance(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Knee Self-efficacy (K-SES)(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Y-Balance Test(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Healthcare Utilization(Baseline)
- Moderate-to-vigorous Physical Activity(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Body mass index(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Number of Exercise Sessions Completed during the Maintenance Stage(Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group))
- Weekly Time Spent Completing the Program during the Maintenance Stage(Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group))
- Lean mass index(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Joint-specific Adverse Events during the Maintenance Stage(Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group))
- Consultations with the Study Physiotherapist during the Maintenance Stage(Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group))
- Asymmetries in Jumping Performance(Baseline, 8-weeks, 16-weeks and 24-weeks)
- Fat mass index(Baseline, 8-weeks, 16-weeks and 24-weeks)
研究者
Carolyn Emery
Professor
Sport Injury Prevention Research Centre