Mechanical and Molecular Determinants of Cartilage Response to Exercise
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.
详细描述
Participants will be randomly assigned to 1 of 2 treatment groups. Both groups do the same exercise program 3 times a week for 12 weeks on nonconsecutive days. The only difference is that one group will perform the exercises with small resting periods between exercises as normally done in clinical practice. The other group will have two long rests of 45 minutes during the exercise training session. Before and after the exercise programs, participants will undergo a series of assessments including gait analysis, MRI imaging of knees, tests of muscle strength and physical performance. Questionnaires will be completed. Blood and synovial fluid will be collected as part of this study.
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 (Investigator)
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 79 yo.
- •Clinical diagnosis of primary, early to moderate stage knee osteoarthritis.
- •BMI range < 35 kg/m
- •Sedentary lifestyle
- •Knee joint is the most painful joint in the body.
- •Ability to speak and understand English.
- •Willingness to comply with all study procedures and be available for the duration of the study.
排除标准
- •Non-OA disease of the knee.
- •Advanced knee osteoarthritis
- •Knee injection in the past 3 months.
- •Major knee trauma/surgery in the past 5 years or previous knee surgery with hardware limiting cartilage assessment..
- •Participate in regular exercise or physical activity .
- •Participation in an intervention study for knee OA.
- •Currently using a cane, walker or crutches to walk.
- •History of cardiovascular disease or hypertension not controlled by medication.
- •Two or more unexplained falls in the past year.
- •Inflammatory, autoimmune disorders, neurological, systemic, muscular, or connective tissue conditions that affect walking or ability to exercise.
- •Contraindication to MRI.
- •Medical condition or characteristic of the participant that could place the individual at increased risk or preclude s/he from complying with study procedures.
- •Pregnant female.
- •Acute or terminal illness.
研究组 & 干预措施
Exercise With Rest
Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours.
干预措施: Exercise with Rest (Behavioral)
Exercise Without Rest
Exercise without Rest
干预措施: Exercise without Rest (Behavioral)
结局指标
主要结局
Feasibility of recruitment
时间窗: The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment.
The number of eligible individuals who are randomized out of all eligible individuals.
次要结局
- Safety of interventions(3 months (window of 1 month))
研究者
Sara R. Piva
Professor and Vice Chair for Research
University of Pittsburgh