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

N/ANot Yet RecruitingNCT07404683

University of Valencia60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Adult

Interventions

Low-intensity exercise with BFRDEVICE

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.

High-intensity exercise without BFRPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy, untrained adults * Age between 18 and 65 Exclusion Criteria: * 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.)

Outcomes

Primary Outcomes

Isometric rotator cuff strength

Isometric rotator cuff strength measured with a dynamometer

Time frame: Baseline, 4 weeks and 8 weeks

Rate of perceived exertion

Rate of perceived exertion (RPE) measured using the Borg scale (0-10)

Time frame: Periprocedural

Perceived tolerance

Participant tolerance to the training protocol will be assessed at the end of the intervention using a 5-point Likert scale, ranging from very well tolerated (5), well tolerated (4), neutral (3), poorly tolerated (2), to very poorly tolerated (1).

Time frame: 8 weeks

Occurrence of adverse effects

Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report

Time frame: Immediately after the intervention, 1 hour, 6 hours, 24 hours, 1 week

Surface electromyography

Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)

Time frame: Periprocedural

Muscle Thickness

Muscle thickness of the deltoid, biceps brachii, triceps brachii, and pectoralis major will be assessed using ultrasound imaging

Time frame: Baseline, 4 weeks, 8 weeks