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

NCT07404683 — Not applicable, Not yet recruiting, 60 participants, University of Valencia

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

Registry	NCT07404683
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	University of Valencia (Other)
Conditions	Healthy Adult
Interventions	High-intensity exercise with BFR, Low-intensity exercise with BFR, High-intensity exercise without BFR (Device, procedure)
Dates	start 2026-09-01 (estimated), primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-02-11, last updated 2026-06-11

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
High-intensity exercise with blood occlusion	Experimental	Device: High-intensity exercise with BFR	Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, and 50% blood occlusion
Low-intensity exercise with blood occlusion	Active comparator	Device: Low-intensity exercise with BFR	Sixteen sessions of exercise during 8 weeks, 30% repetition maximum, and 50% blood occlusion
High-intensity exercise without blood occlusion	Active comparator	Procedure: High-intensity exercise without BFR	Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, 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.
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.
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.

+Outcome measures

Primary outcomes

Isometric rotator cuff strength [Baseline, 4 weeks and 8 weeks]: Isometric rotator cuff strength measured with a dynamometer
Rate of perceived exertion [Periprocedural]: Rate of perceived exertion (RPE) measured using the Borg scale (0-10)
Perceived tolerance [8 weeks]: 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).
Occurrence of adverse effects [Immediately after the intervention, 1 hour, 6 hours, 24 hours, 1 week]: 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
Surface electromyography [Periprocedural]: Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)
Muscle Thickness [Baseline, 4 weeks, 8 weeks]: Muscle thickness of the deltoid, biceps brachii, infraspinatus, supraspinatus and subescapularis will be assessed using ultrasound imaging

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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.)

+Investigators

Adrian Escriche-Escuder, PhD, Principal investigator, University of Valencia