Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in Joint Specific Self-Reported Function
研究概览
简要总结
Negative outcomes impact individuals with a history of ACL reconstruction (ACLR) despite completion of formal rehabilitation and clearance to return to physical activity (PA). Focused exercises and targeted health education may improve these negative outcomes and increase quality of life. The purpose of this study is determine the effects of an 8-week rehabilitation program on strength, sensorimotor function, functional performance and patient-reported outcomes in patients with a history of ACLR. A secondary aim will be to identify baseline PA levels and dietary intake patterns in these individuals. Participants will complete standard knee radiographs and all baseline measures, and resume normal activities of daily living for one-week while wearing an accelerometer to quantify PA levels and complete two, 24-hour dietary recalls to examine dietary patterns. After one-week, participants will come back to the laboratory and complete the pre-intervention assessments prior to randomization to the exercise or control group. After 8-weeks, participants will complete all outcome assessments 24-48 hours, 1-month and 3-months post exercise completion. The investigators hypothesize the intervention group will have significantly better outcomes post-intervention compared to the control group. In addition, the investigators hypothesize areas of educational and behavioral intervention related to PA engagement and dietary strategies to support weight management will be needed.
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
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of unilateral ACL reconstruction,
- •History of injuring their knee playing or training for sports (recreational or organized),
- •Have been cleared to participate in activity, do not have radiographic evidence of post-traumatic osteoarthritis,
- •Are free of neurological disorders, cardiopulmonary disease or any other condition that may impact their ability to participate
排除标准
- •ACL reconstruction >10 years,
- •Injury to either lower extremity within the last 6-weeks,
- •Surgery to either limb within the last year,
- •A BMI > 30
结局指标
主要结局
Change in Joint Specific Self-Reported Function
时间窗: Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post
Participants will complete the Knee Injury and Osteoarthritis Outcome (KOOS) survey to assess self-reported knee joint function across five domains (pain, symptoms, activities of daily living, sport and recreation, and quality of life). The questionnaire will include 42 questions across the domains, that are scored on a 5-point Likert scale. Each subscale is scored separately, and range from 0-100 (100=perfect self-reported knee function). The scores are transformed for each subscale as follows: 100-(actual raw score x 100)/ possible raw score. Participants will complete the survey at the time of consent, one week later just prior to the initiation of the intervention, up to 48 hours after completion of the intervention, then at 1 and 3 month follow up visits. Data will be presented longitudinally as the change in self-reported function over the duration of the study, up to three months.
次要结局
- Change in Fear Avoidance Behaviors(Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post)
- Change in Knee related Self-Efficacy(Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post)
- Change in Functional Abilities(Baseline, pre-intervention )(one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post)
- Change in Static Balance(Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post)
- Change in General Health-Related Quality of Life(Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post)
- Change in Fear of Movement(Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-exercise completion, 1-month post, 3-months post)
- Change in Dynamic Balance(Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post)
- Change in Landing Errors(Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post)
- Change in Strength(Baseline, pre-intervention (one week later just prior to the initiation of the intervention), 24-48 hours post-intervention, 1-month and 3-months post)
研究者
Johanna M. Hoch
Assistant Professor
University of Kentucky