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临床试验/NCT06942065
NCT06942065已完成不适用

Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年6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
25
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty

详细描述

The present study evaluated the impact of blood flow restriction training in the context of three-week outpatient rehabilitation following TKA, in accordance with the guidelines of the German Pension Insurance System. The in-rehabilitation and post-rehabilitation muscle status, strength, knee functionality, impairments in daily life and subjective pain perception were measured.

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 (Participant, Outcomes Assessor)

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

  • •Physical Fitness for Rehabilitation
  • •Primary TKA surgery
  • •BMI < 35

排除标准

  • •Sickle Cell Anemia
  • •Vascular Intervention on the lower extremities
  • •Open Wounds

研究组 & 干预措施

Control Group

Sham Comparator

Control sham condition which performed the exercise with a fixed pressure of 20mmHg

干预措施: Sham-BFR (Procedure)

Blood Flow Restriction Group

Experimental

This intervention groups performed training on the operated limb with a BFR pressure corresponding to 60% of the individual limb occlusion pressure

干预措施: Blood Flow Restriction Training (Procedure)

结局指标

主要结局

Postoperative Pain

时间窗: Pre- to 6 weeks Post Rehabilitation

Postoperative Pain was assessed by visual analoge scale (0-100mm)

Muscle Strength

时间窗: Pre- to 6 weeks Post Rehabilitation

Isometric muscle strength was measured on a DDRobotec (Dynamic Devices AG, Zurich, Switzerland), a pneumatic, computer-controlled leg press

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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