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临床试验/NCT07043569
NCT07043569招募中不适用

Clinical-randomized Trial of the Effect of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Anterior Cruciate Ligament Reconstruction

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Muscle Strength (N)

研究概览

简要总结

With the intention of improving rehabilitation after anterior cruciate ligament reconstruction, the present project investigates the influence of a targeted strength and blood flow restriction training intervention (BFR training) on the regeneration of muscle mass, strength and functionality of the knee joint. BFR training is characterized by the combination of external venous vascular occlusion with light strength training and still enables users to achieve gains in muscle mass and strength that are comparable to training with high mechanical loads. The positive effects of BFR training in the course of knee arthroplasty have already been demonstrated by our working group as a prehabilitative approach, i.e. as a training intervention prior to surgery. In the present project, the framework conditions of outpatient rehabilitation at the Bonn Center for Outpatient Rehabilitation will now be used to prove whether sports science-controlled strength and BFR training has a similar effect in the postoperative rehabilitation phase. The interventions are carried out as part of the exercise therapy units in outpatient rehabilitation ETM01 in accordance with the S2k guideline on anterior cruciate ligament rupture. Strength and BFR training in medical training therapy supplements the daily exercise therapy to ensure implementation in the rehabilitation process in line with the guidelines.

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
Single (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

  • •ACL reconstruction
  • •Ability to take part in an outpatient rehabilitation

排除标准

  • •Sickle Cell anemia
  • •iatrogenic changes in the vessels of the lower limbs (stents, bypasses)
  • •inflammation of the lower extremities

研究组 & 干预措施

Control Group

Active Comparator

Control group will perform the exercise protocols with a sham-BFR pressure of 20 mmHg.

干预措施: Resistance Training with Sham-BFR (Other)

Intervention Group

Experimental

Intervention group will perform the exercise protocols with a BFR pressure corresponding to 60% of the individual limb occlusion pressure.

干预措施: Resistance Exercise with BFR (Other)

结局指标

主要结局

Muscle Strength (N)

时间窗: Pre- (before Rehabilitation) to Post-Rehabilitation (immediately after three weeks of exercise intervention up to 1 year follow up)

isoemtric maximal strength of both legs will assessed on a isokinetic 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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