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临床试验/NCT07043114
NCT07043114已完成不适用

Influence of Walking Training in Combination With Blood Flow Restriction Training on Muscle Hypertrophy and Quality of Life in PAOD IIa

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年8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
10
试验地点
1
主要终点
Muscle Strength

研究概览

简要总结

In peripheral arterial occlusive disease (PAOD), there is a partial (stenosis) or complete occlusion of peripheral arteries, which leads to reduced arterial blood flow. The cause is atherosclerosis in about 95% of cases and in most cases the lower extremities are affected. The disease is further divided into different stages; stage II is relevant for the present study, specifically IIa. In this case, pain in the legs occurs after a few hundred meters of exertion, e.g. when walking, forcing patients to stop. This condition is also commonly known as intermittent claudication. The therapy of choice is regular gait training, a symptomatic therapy, as the initial cause, atherosclerosis, cannot be treated causally. In the present project, this gait training is supplemented by placing BFR cuffs proximally around the thighs of the patients while walking. The aim is to promote angioneogenesis, which leads to a reduction in symptoms and a corresponding increase in quality of life. A further effect of this can be greater muscle hypertrophy, which also has a positive effect.

详细描述

Any patient with stage IIa PAOD can be recruited. Patients will complete a walking training with an additionall BFR-pressure applied bilateraly and corresponding to 60% of the individual limb occlusion pressure. The training consists of the patients walking on a treadmill twice a week for a total of six weeks until their pain becomes too severe and they have to take a break. After a one-minute break, this is increased again until the pain reaches its maximum. This is done a total of three times per appointment. After the first three weeks, the intensity of the training is increased by setting a higher speed on the treadmill.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •PAOD Typ 2
  • •Eligibitly to exercise on a treadmill

排除标准

  • •PAOD > Typ 2
  • •Iatrogenic changes in the vessels of the lower extremities (e.g. Stents)
  • •Sickle Cell Anemia
  • •Open Wounds/Infections on the lower extremities

研究组 & 干预措施

Intervention Group

Experimental

Patients with PAOD Typ II will perform a six-week walking training with BFR

干预措施: BFR-Walking (Other)

结局指标

主要结局

Muscle Strength

时间窗: Pre- (Baseline) to Post-Intervention Phase (after twelve weeks of training intervention)

Isometric Maximal Strength of the Knee Extensors analyzed by Dynamometer (N)

Quality of Life Score

时间窗: Pre- (Baseline) to Post-Intervention Phase (after twelve weeks of training intervention)

Quality of Life assessed by Short-Form 36 Survey

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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