Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty
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
- Self-reported function
研究概览
简要总结
The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care.
详细描述
Patients with lower levels of function prior to total knee arthroplasty (TKA) attain lower functional endpoints after surgery. Therapeutic exercise improves function in patients with arthritis of the knee, yet little evidence has examined the impact of pre-operative exercise for TKA.
Single blinded randomized clinical trial comparing a pre-operative home exercise program to pre-operative usual care for patients who are waiting for TKA.Comparison group is usual care within the health region which does not include pre-operative rehabilitation program.
Primary outcome: WOMAC function subscale. Secondary outcomes: 1) quality of life; 2) ambulation; 3) self-efficacy; 4) anxiety; 5) patient satisfaction; 6) cost-effectiveness of this intervention.
Total Enrollment: 230 patients
If the intervention improves function prior to surgery, results will be clinically applicable for patients waiting for surgery
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary unilateral total knee arthroplasty
- •poor functional status (WOMAC=50 or greater)
- •50 yrs or older
- •reside within health region
- •understands English
排除标准
- •unicompartmental total knee arthroplasty
- •revision surgery
结局指标
主要结局
Self-reported function
时间窗: 5 evaluations within 6 months after surgery
Self-reported function
次要结局
- Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction(5 evaluations within 6 months after surgery)
- self-efficacy(5 evaluations within 6 months after surgery)
- ambulation, anxiety and patient satisfaction(5 evaluations within 6 months after surgery)
- patient satisfaction(5 evaluations within 6 months after surgery)
- anxiety(5 evaluations within 6 months after surgery)