About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
DeviceParticipants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up: Group 1) BFR Group with 50% AOP compression Group 1 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 30-15-15-15 at 40% 1RM (repetition maximum) Exercise : External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.
Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
DeviceParticipants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up: Group 2) BFR Group with 10% AOP compression Group 2 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 15-15-15-15 at 70% 1RM Exercise : External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.
Treatment groups
Trial outcomes
Primary outcomes
Isokinetic strength
Concentric peak torque (Nm) IR-ER at 60°/sec
Isokinetic strength
Concentric peak torque (Nm) IR-ER at 240°/sec
Isokinetic strength
Eccentric peak torque (Nm) IR-ER at 60°/sec
Isokinetic strength
Concentric ratio (ER conc 60°/ IR conc 60°)
Secondary outcomes
Shoulder mobility
Flexion
Shoulder mobility
Abduction
Shoulder mobility
Internal rotation at 90° abduction
Shoulder mobility
External rotation at 90° abduction
Locations
Sponsors and contacts
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