NCT06928181已完成不适用
Effects of Passive Blood-Flow-Restriction Training on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty
University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Muscle Mass
研究概览
简要总结
This study investigated the effects of passive Blood-Flow-Restriction Training after elective Total Knee Arthroplasty Surgery on Muscle Atrophy and Postoperative Pain.
详细描述
This is the first study invesigating the effects of passive Blood-Flow-Restriction Training on Muscle Atrophy and Postoperative Pain after Elective Total Knee Arthroplasty 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study includes all patients with a medical indication for surgical treatment of the lower extremity (total or partial knee arthroplasty) who are eligible for either inpatient or outpatient rehabilitation.
- •All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving comprehensive explanation, counseling, and information.
- •All patients have consented to the surgical procedure and received medical clearance for surgery from both the orthopedic and anesthesiology departments.
排除标准
- •Acute or chronic infections of the extremities
- •Open wounds on the lower extremity
- •Pregnancy and breastfeeding
- •Patients who are unable to understand the patient information and study design (e.g., due to language barriers), or whose compliance is deemed insufficient by the study team
研究组 & 干预措施
Control
Sham Comparator
Sham-BFR Intervention with 20mmHg
干预措施: Sham-BFR (Other)
Intervention
Experimental
BFR-Intervention with 80% of the 1RM
干预措施: Blood Flow Restriction Training (Other)
结局指标
主要结局
Muscle Mass
时间窗: Three Months
Lean Body Mass in DEXA anaylsis
Postoperative Pain
时间窗: Three Months
0-100 mm VAS
次要结局
未报告次要终点
研究者
Alexander Franz
Dr. med., B.Sc.
University Hospital, Bonn
研究点 (1)
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