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

ConditionHealthy Adult
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Valencia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy, untrained adults

Age between 18 and 65

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: High-intensity exercise with blood occlusionExperimental treatment 1 intervention
Group B: Low-intensity exercise with blood occlusionActive comparator 1 intervention
Group C: High-intensity exercise without blood occlusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Isometric rotator cuff strength

Isometric rotator cuff strength measured with a dynamometer

Time frame
Baseline, 4 weeks and 8 weeks
2

Rate of perceived exertion

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

Time frame
Periprocedural
3

Perceived tolerance

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).

Time frame
8 weeks
4

Occurrence of adverse effects

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

Time frame
Immediately after the intervention, 1 hour, 6 hours, 24 hours, 1 week

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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