NCT00951990已完成1 期
A Multicenter Randomized Controlled Trail of Ergometer Cycling After Hip and Knee Replacement Surgery
Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein10 个研究点 分布在 1 个国家目标入组 457 人开始时间: 2005年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 457
- 试验地点
- 10
- 主要终点
- WOMAC Physical Function
研究概览
简要总结
Despite the widespread use of hip and knee replacement surgery, there is a considerable lack of consensus regarding postoperative treatment and rehabilitation, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices.
In particular there are no recommendations regarding the use of ergometer cycling after hip or knee replacement surgery.
Therefore the investigators initiated a multicenter controlled clinical trial evaluating the effect of ergometer cycling versus no ergometer cycling after hip or knee replacement 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis of diagnosis of osteoarthritis or femoral head necrosis
排除标准
- •A history of septic arthritis
- •Hip fracture
- •Intraoperative complications
- •History of implant surgery on the joint to be operated on
- •Rheumatoid arthritis
- •Amputations
- •Inability of complete the questionnaires because of cognitive or language difficulties
结局指标
主要结局
WOMAC Physical Function
时间窗: 3 months to 24 months
次要结局
- Patient satisfaction(3 months to 24 months)
- WOMAC Pain and Stiffness(3 months to 24 months)
- SF-36(3 months to 24 months)
- Lequesne Hip or Knee Score(3 months to 24 months)
研究者
研究点 (10)
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