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

NCT07404683 | Not Yet Recruiting

• 1 other identifier: 2025-FIS-4211701
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Adult

Keywords

blood flow restriction; exercise; high-intensity; rotator cuff

Outcome Measures

Primary Outcomes (6)

• Isometric rotator cuff strength

  Isometric rotator cuff strength measured with a dynamometer

  Baseline, 4 weeks and 8 weeks

• Rate of perceived exertion

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

  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).

  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

  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)

  Periprocedural

• Muscle Thickness

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

  Baseline, 4 weeks, 8 weeks

Study Arms (3)

High-intensity exercise with blood occlusion

EXPERIMENTAL

Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, and 50% blood occlusion

Device: High-intensity exercise with BFR

Low-intensity exercise with blood occlusion

ACTIVE COMPARATOR

Sixteen sessions of exercise during 8 weeks, 30% repetition maximum, and 50% blood occlusion

Device: Low-intensity exercise with BFR

High-intensity exercise without blood occlusion

ACTIVE COMPARATOR

Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, without blood occlusion

Procedure: High-intensity exercise without BFR

Interventions

High-intensity exercise without BFR PROCEDURE

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.

High-intensity exercise without blood occlusion

High-intensity exercise with BFR DEVICE

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.

High-intensity exercise with blood occlusion

Low-intensity exercise with BFR DEVICE

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.

Low-intensity exercise with blood occlusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, untrained adults
• Age between 18 and 65

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Valencia: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Adrian Escriche-Escuder, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Escriche-Escuder, PhD

CONTACT

+34 963 98 38 55; adrian.escriche@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02