Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure
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
- 否
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
研究组 & 干预措施
Control
Patient will not use BFR
Placebo 10% of pressure for arterial occlusion
Patient will use BFR sub optimally as described in the literature
干预措施: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability (Device)
Interventional 50% of pressure for arterial occlusion
Patient will use the minimal pressure of 50% of arterial occlusion known to be effective in the literature
干预措施: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability (Device)
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
Arnaud Meylan
Doctor
Ensemble Hospitalier de la Côte