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临床试验/NCT06430567
NCT06430567尚未招募不适用

Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure

Ensemble Hospitalier de la Côte0 个研究点目标入组 50 人开始时间: 2024年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Isokinetic strength

研究概览

简要总结

The goal of this clinical trial is to evaluate the effects of Blood Flow Restriction (BFR) training on post-surgery rehabilitation following the Latarjet procedure in athletes aged 18-35.

The main questions it aims to answer are:

Does BFR training improve scapular belt muscle strength post-surgery? Does BFR training enhance shoulder function during rehabilitation?

Researchers will compare three groups:

BFR Group with 50% AOP [arterial occlusion pressure] compression BFR Placebo Group with 10% AOP compression Control Group

Participants will:

Perform the same four strengthening exercises twice a week Complete 16 semi-autonomous strength training sessions over 8 weeks Undergo isokinetic and isometric strength tests, shoulder mobility assessments, and complete self-assessment questionnaires.

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, Investigator)

盲法说明

Participants between placebo and intervention group will be blinded

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-35 years
  • Indication for shoulder stabilization surgery using the Latarjet procedure (documented anterior dislocations with proof of emergency reduction, with or without hypermobility and confirmation of traumatic capsulo-ligamentous injury by MRI).
  • Regular exercise (min. 1x / week)
  • Signed the informed consent form for the study.

排除标准

  • Pregnant or breast-feeding women
  • Active oncological disease under treatment. (Patient with stable oncological disease eligible)
  • Adverse events during the 6-week post-operative period such as:-Fracture/displacement of the reconstructed bone-Luxation of the operated shoulder-Requirement for emergency hospitalization
  • History of deep vein thrombosis/pulmonary embolism
  • Inability to follow study procedures, due to language problems, psychological disorders, dementia.
  • Need for skin grafting following shoulder stabilization surgery
  • Coronary heart disease
  • Unstable hypertension
  • Peripheral vascular disease
  • Hypercoagulable states (blood coagulation disorders)
  • Left ventricular dysfunction
  • Hemophilia

结局指标

主要结局

Isokinetic strength

时间窗: Preoperative and at 14 weeks postoperative

Concentric peak torque (Nm) IR-ER at 60°/sec

Isometric strength

时间窗: Preoperative and at 14 weeks postoperative

Flexion in the scapular plane (Nm)

次要结局

  • Shoulder mobility(Preoperative and at 14 weeks postoperative)
  • Scapular girdle stability(Preoperative and at 14 weeks postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arnaud Meylan

Doctor

Ensemble Hospitalier de la Côte

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