Healthy AdultNCT07404683
Safety and Effects of High-Intensity Blood Flow Restriction Training in the Rotator Cuff
A study testing High-intensity exercise with BFR, Low-intensity exercise with BFR and High-intensity exercise without BFR in people with Healthy Adult, run by University of Valencia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- High-intensity exercise with BFR, Low-intensity exercise with BFR and High-intensity exercise without BFR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, untrained adults
- Age between 18 and 65
Who cannot join
- 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.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Healthy Adult
- Being tested
- High-intensity exercise with BFR, Low-intensity exercise with BFR, High-intensity exercise without BFR
- Keywords
- blood flow restriction, exercise, high-intensity, rotator cuff
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity exercise with BFRDevice
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 BFRDevice
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 BFRProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity exercise with blood occlusion | Experimental | Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, and 50% blood occlusion Receives: Device: High-intensity exercise with BFR |
| Low-intensity exercise with blood occlusion | Active comparator | Sixteen sessions of exercise during 8 weeks, 30% repetition maximum, and 50% blood occlusion Receives: Device: Low-intensity exercise with BFR |
| High-intensity exercise without blood occlusion | Active comparator | Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, without blood occlusion Receives: Procedure: High-intensity exercise without BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric rotator cuff strength
Isometric rotator cuff strength measured with a dynamometer
Measured: Baseline, 4 weeks and 8 weeks
Rate of perceived exertion
Rate of perceived exertion (RPE) measured using the Borg scale (0-10)
Measured: Periprocedural
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).
Measured: 8 weeks
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
Measured: Immediately after the intervention, 1 hour, 6 hours, 24 hours, 1 week
Surface electromyography
Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)
Measured: Periprocedural
Muscle Thickness
Muscle thickness of the deltoid, biceps brachii, infraspinatus, supraspinatus and subescapularis will be assessed using ultrasound imaging
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Escriche Escuder, University of Valencia
- Investigators
- Adrian Escriche-Escuder, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404683
- Sponsor's protocol ID
- 2025-FIS-4211701
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study will be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Utility and Effects After 8 Weeks of High-intensity Strength Training With Blood Flow Restriction in the Rotator Cuff
- ClinicalTrials.gov ID
- NCT07404683
- Acronym / sponsor ID
- 2025-FIS-4211701
- Conditions
- Healthy Adult
- Keywords
- blood flow restriction, exercise, high-intensity, rotator cuff
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity exercise with blood occlusion | Experimental | Device: High-intensity exercise with BFRSixteen sessions of exercise during 8 weeks, 70% repetition maximum, and 50% blood occlusion |
| Low-intensity exercise with blood occlusion | Active comparator | Device: Low-intensity exercise with BFRSixteen sessions of exercise during 8 weeks, 30% repetition maximum, and 50% blood occlusion |
| High-intensity exercise without blood occlusion | Active comparator | Procedure: High-intensity exercise without BFRSixteen sessions of exercise during 8 weeks, 70% repetition maximum, without blood occlusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy, untrained adults
- Age between 18 and 65
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity exercise with BFRThree 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 | High-intensity exercise with blood occlusion |
| Low-intensity exercise with BFRThree 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. | Device | Low-intensity exercise with blood occlusion |
| High-intensity exercise without BFRThree 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. | Procedure or surgery | High-intensity exercise without blood occlusion |
Primary outcome
Isometric rotator cuff strength
Time frame: Baseline, 4 weeks and 8 weeks
Isometric rotator cuff strength measured with a dynamometer
Rate of perceived exertion
Time frame: Periprocedural
Rate of perceived exertion (RPE) measured using the Borg scale (0-10)
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).
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
Surface electromyography
Time frame: Periprocedural
Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study will be available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adrian Escriche-Escuder, PhD principal investigator
University of Valencia
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity exercise with BFR, Low-intensity exercise with BFR and High-intensity exercise without BFR in people with Healthy Adult, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrian Escriche-Escuder, PhD (+34 963 98 38 55, adrian.escriche@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric rotator cuff strength (time frame: Baseline, 4 weeks and 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.