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NCT Number: NCT07404683

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. Isometric rotator cuff strength

    Time frame: Baseline, 4 weeks and 8 weeks

    Isometric rotator cuff strength measured with a dynamometer

  2. Rate of perceived exertion

    Time frame: Periprocedural

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

  3. Perceived tolerance

    Time frame: 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).

  4. Occurrence of adverse effects

    Time frame: 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

  5. Surface electromyography

    Time frame: Periprocedural

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

  6. Muscle Thickness

    Time frame: Baseline, 4 weeks, 8 weeks

    Muscle thickness of the deltoid, biceps brachii, infraspinatus, supraspinatus and subescapularis will be assessed using ultrasound imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Adrian Escriche-Escuder, PhD

CONTACT

[email protected]

+34 963 98 38 55

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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