A Comparison of Treatment Methods for Patients Following Total Knee Replacement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).
研究概览
简要总结
Although total knee replacement (TKR) improves pain in numerous patients, it does not resolve many of the substantial functional limitations and physical inactivity that existed for a long time prior to the surgery. Exercise is an intervention that could improve these long-term limitations. To promote these improvements, exercise should be implemented at later stage post TKR when patients can tolerate doses of exercise sufficiently high to promote substantial changes. To date, we just don't have enough good research to tell us which type of exercise works best for which patients and under which circumstances at later stage post TKR. This research study will provide evidence for recommended interventions during the later stage post TKR. The specific research questions are: (1) How do group exercise in the community and individual exercise in rehabilitation clinic compare with usual medical care on physical function and activity outcomes? (2) Who are the patients most likely to respond to each exercise intervention? (3) Are the approaches safe?
详细描述
This is a comparative effectiveness study, designed as a 3-group single-blind randomized clinical trial. Two hundred forty older adults who underwent TKR at least 2 months prior and are otherwise eligible will be randomized into one of three treatment approaches: 1) clinic-based individual outpatient rehabilitative exercise; 2) community-based group exercise classes; or 3) usual medical care. Subjects will be treated for 3 months. Data will be collected before intervention, after intervention (3 months), and 6 months after randomization. Physical function is a primary outcome and will be assessed by the Western Ontario and McMaster Universities Arthritis Index and a battery of performance-based tests germane to patients post TKR that includes ability to walk, manage stairs, lift from the floor and the chair, and one-leg balance. We will also use an accelerometer-based monitor that provides a real-time measure of physical activity during normal daily living and is able to accurately capture most levels of activity. Linear mixed models will be fitted to compare the changes in outcome across groups. Logistic regression will identify patient characteristics that predict functional recovery in the exercise groups. Survival analysis and instrumental variable methods will be used to compare attrition, adherence and adverse events between groups.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral TKR 2 to 4 months prior
- •Older than 60 years of age
- •Experience functional limitation in daily activities (score in WOMAC-PF of at least 9 points)
- •Speak sufficient English to understand study instructions
- •Have medical clearance to participate in the study
- •Are willing to be randomized to one of the 3 treatment arms
排除标准
- •Have absolute or relative contraindications to exercise
- •Have history of uncontrolled cardiovascular disease or hypertension
- •Are unable to walk 50 meters without an assistive device
- •Have history of muscular or neurological disorder that affect lower extremity function
- •Regular participation in exercise
- •Terminal illness
- •Planning to have another joint replacement during the next 12 months
- •Plan not to be around during the next 12 months
研究组 & 干预措施
Clinic-based outpatient exercise group
Subjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
干预措施: Clinic-based outpatient exercise group (Other)
Community-based exercise group
Subjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
干预措施: Community-based exercise group (Other)
Wait-listed usual medical care
Wait-listed usual medical care - no intervention provided by study.
结局指标
主要结局
The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).
时间窗: Baseline, 3 and 6 months
WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.
次要结局
- Composite Score of Performed-based Tests of Physical Function.(Baseline, 3 and 6 months)
研究者
Sara R. Piva
Dr.
University of Pittsburgh