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Not yet recruiting NCT07404683

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

No phase Interventional Healthy Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-intensity exercise with BFR, Low-intensity exercise with BFR, High-intensity exercise without BFR.
Who it may be relevant to
Registry conditions: Healthy Adult. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Isometric rotator cuff strength [Time frame: Baseline, 4 weeks and 8 weeks]
  • Rate of perceived exertion [Time frame: Periprocedural]
  • Perceived tolerance [Time frame: 8 weeks]
  • Occurrence of adverse effects [Time frame: Immediately after the intervention, 1 hour, 6 hours, 24 hours, 1 week]
  • Surface electromyography [Time frame: Periprocedural]
  • Muscle Thickness [Time frame: Baseline, 4 weeks, 8 weeks]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07404683 · 2025-FIS-4211701

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗