Safety and Effects of High-Intensity Blood Flow Restriction Training in the Rotator Cuff

Официальное название

Safety, Utility and Effects After 8 Weeks of High-intensity Strength Training With Blood Flow Restriction in the Rotator Cuff

Обзор

This study aims to analyze the effects of an 8-week strength training program combining different exercise intensities and blood flow restriction (BFR) conditions on safety, tolerability, muscle adaptations, and physical performance variables. Three training modalities will be compared: 1) high-intensity exercise with BFR therapy; 2) low-intensity exercise with BFR therapy; and 3) high-intensity exercise without BFR therapy. All groups will perform the same exercise modality, differing only in intensity and the application of BFR. Participants will be randomly assigned to one of the three groups and will undergo a 8-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.

Вмешательства

• Устройство High-intensity exercise with BFR
  Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 70% RM and a 50% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
• Устройство Low-intensity exercise with BFR
  Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 50% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
• Процедура High-intensity exercise without BFR
  Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 70% RM and a without flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.

Первичные конечные точки

• Isometric rotator cuff strength [Срок оценки: Baseline, 4 weeks and 8 weeks]
• Rate of perceived exertion [Срок оценки: Periprocedural]
• Perceived tolerance [Срок оценки: 8 weeks]
• Occurrence of adverse effects [Срок оценки: Immediately after the intervention, 1 hour, 6 hours, 24 hours, 1 week]
• Surface electromyography [Срок оценки: Periprocedural]
• Muscle Thickness [Срок оценки: Baseline, 4 weeks, 8 weeks]

Критерии участия

Критерии включения

• Healthy, untrained adults
• Age between 18 and 65

Критерии исключения

• Current participation in an upper limb strength training program
• Presence of comorbidities that increase cardiovascular risk (uncontrolled ischemic heart disease, uncontrolled hypertension, diabetes, etc.)
• Patients with more than one thromboembolism risk factor (obesity, history of thrombosis, prolonged immobilization, recent surgery, use of contraceptives, etc.)
• Current diagnosis of any pathology affecting the cervical spine, shoulder, and/or thoracic spine
• History of surgery in the last year
• Use of ergogenic aids or medications that affect muscle metabolism (anabolic steroids, testosterone, creatine, protein supplements, corticosteroids, chronic use of nonsteroidal anti-inflammatory drugs, etc.)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07404683 · 2025-FIS-4211701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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