Clinical trial NCT06430567: Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure
Official title: Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Dislocation
Keywords: Blood flow restriction
Latarjet surgery
Rehabilitation
Lead sponsor: Ensemble Hospitalier de la Côte
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Isokinetic strength
timeFrame: Preoperative and at 14 weeks postoperative
measure: Isokinetic strength
timeFrame: Preoperative and at 14 weeks postoperative
measure: Isokinetic strength
timeFrame: Preoperative and at 14 weeks postoperative
measure: Isokinetic strength
timeFrame: Preoperative and at 14 weeks postoperative
measure: Isokinetic strength
timeFrame: Preoperative and at 14 weeks postoperative
measure: Isometric strength
timeFrame: Preoperative and at 14 weeks postoperative
measure: Isometric strength
timeFrame: Preoperative and at 14 weeks postoperative
measure: Isometric strength
timeFrame: Preoperative and at 14 weeks postoperative
Secondary outcomes:
measure: Shoulder mobility
timeFrame: Preoperative and at 14 weeks postoperative
measure: Shoulder mobility
timeFrame: Preoperative and at 14 weeks postoperative
measure: Shoulder mobility
timeFrame: Preoperative and at 14 weeks postoperative
measure: Shoulder mobility
timeFrame: Preoperative and at 14 weeks postoperative
measure: Shoulder mobility
timeFrame: Preoperative and at 14 weeks postoperative
measure: Scapular girdle stability
timeFrame: Preoperative and at 14 weeks postoperative
measure: Scapular girdle stability
timeFrame: Preoperative and at 14 weeks postoperative
measure: Scapular girdle stability
timeFrame: Preoperative and at 14 weeks postoperative
Other outcomes:
Locations:
Study officials:
affiliation: EHC Morges
name: Bauer Stefan, MD
role: STUDY_DIRECTOR
References: