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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07404683
Enrollment
60
Registered
2026-02-11
Start date
2026-09-01
Completion date
2028-06-01
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult

Keywords

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

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.

Interventions

DEVICEHigh-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.

DEVICELow-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.

PROCEDUREHigh-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.

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
Isometric rotator cuff strengthBaseline, 4 weeks and 8 weeksIsometric rotator cuff strength measured with a dynamometer
Rate of perceived exertionPeriproceduralRate of perceived exertion (RPE) measured using the Borg scale (0-10)
Perceived tolerance8 weeksParticipant 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 effectsImmediately after the intervention, 1 hour, 6 hours, 24 hours, 1 weekOccurrence 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 electromyographyPeriproceduralSurface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)
Muscle ThicknessBaseline, 4 weeks, 8 weeksMuscle thickness of the deltoid, biceps brachii, infraspinatus, supraspinatus and subescapularis will be assessed using ultrasound imaging

Contacts

CONTACTAdrian Escriche-Escuder, PhD
adrian.escriche@uv.es+34 963 98 38 55
PRINCIPAL_INVESTIGATORAdrian Escriche-Escuder, PhD

University of Valencia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026