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

February 7, 2026 updated by: Adrián Escriche Escuder, University of Valencia

Safety, Utility and Effects After 8 Weeks of High-intensity Strength Training With Blood Flow Restriction 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-intensity exercise with blood occlusion
Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, and 50% blood occlusion
Device: High-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.
Active Comparator: Low-intensity exercise with blood occlusion
Sixteen sessions of exercise during 8 weeks, 30% repetition maximum, and 50% blood occlusion
Device: Low-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.
Active Comparator: High-intensity exercise without blood occlusion
Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, without blood occlusion
Procedure: High-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface electromyography
Time Frame: Periprocedural
Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)
Periprocedural
Isometric rotator cuff strength
Time Frame: Baseline, 4 weeks and 8 weeks
Isometric rotator cuff strength measured with a dynamometer
Baseline, 4 weeks and 8 weeks
Rate of perceived exertion
Time Frame: Periprocedural
Rate of perceived exertion (RPE) measured using the Borg scale (0-10)
Periprocedural
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).
8 weeks
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
Immediately after the intervention, 1 hour, 6 hours, 24 hours, 1 week
Muscle Thickness
Time Frame: Baseline, 4 weeks, 8 weeks
Muscle thickness of the deltoid, biceps brachii, triceps brachii, and pectoralis major will be assessed using ultrasound imaging
Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Adrian Escriche-Escuder, PhD, University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-FIS-4211701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data that support the findings of this study will be available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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