Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
  Participants 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
• Устройство Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
  Participants 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

Первичные конечные точки

• Isokinetic strength [Срок оценки: Preoperative and at 14 weeks postoperative]
• Isokinetic strength [Срок оценки: Preoperative and at 14 weeks postoperative]
• Isokinetic strength [Срок оценки: Preoperative and at 14 weeks postoperative]
• Isokinetic strength [Срок оценки: Preoperative and at 14 weeks postoperative]
• Isokinetic strength [Срок оценки: Preoperative and at 14 weeks postoperative]
• Isometric strength [Срок оценки: Preoperative and at 14 weeks postoperative]
• Isometric strength [Срок оценки: Preoperative and at 14 weeks postoperative]
• Isometric strength [Срок оценки: Preoperative and at 14 weeks postoperative]

Вторичные конечные точки (8)

• Shoulder mobility [Срок оценки: Preoperative and at 14 weeks postoperative]
• Shoulder mobility [Срок оценки: Preoperative and at 14 weeks postoperative]
• Shoulder mobility [Срок оценки: Preoperative and at 14 weeks postoperative]
• Shoulder mobility [Срок оценки: Preoperative and at 14 weeks postoperative]
• Shoulder mobility [Срок оценки: Preoperative and at 14 weeks postoperative]
• Scapular girdle stability [Срок оценки: Preoperative and at 14 weeks postoperative]
• Scapular girdle stability [Срок оценки: Preoperative and at 14 weeks postoperative]
• Scapular girdle stability [Срок оценки: Preoperative and at 14 weeks postoperative]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06430567 · EHC Morges BFR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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