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临床试验/NCT06928181
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

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Franz

Dr. med., B.Sc.

University Hospital, Bonn

研究点 (1)

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