Rotator Cuff InjuryS-TRONGERNCT06788327
Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair
A study testing Standard rehabilitation and Blood Flow Restriction Therapy in people with Rotator Cuff Injury and Rotator Cuff Tears, run by University of Valencia at 1 site in Chile.
Trial summary
The goal of this clinical trial is to determine the effectiveness of postoperative standard exercises with blood flow restriction therapy (BFRT) versus standard exercises alone on shoulder muscle strength and mass in participants with surgically treated rotator cuff tear. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Injury, Rotator Cuff Tears, Rotator Cuff Repair
- What is being tested?
- Standard rehabilitation and Blood Flow Restriction Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 3 Mar 2025to 31 Aug 2027
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-65 years
- Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging
- Undergoing arthroscopic rotator cuff repair
- Be able to read and understand Spanish
Who cannot join
- Massive irreparable rotator cuff tear
- Concomitant fracture
- Labral or nerve injury
- Suspicious of developing a frozen shoulder
- Revision surgery after rotator cuff repair
- Previous corticosteroid injection (< 6 months)
Show all 9Show fewer
- Recent surgery (< 1 year) in the contralateral shoulder
- History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia or clotting disorders
- Severe or uncontrolled hypertension, or any comorbid condition that impedes participants to complete the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Clínica RedSalud Mayor
Temuco, Cautín, 4800580
Daniela Mansilla, +56996521664, daniela.mansilla@redsalud.cl
Felipe Ponce-Fuentes, MSc
About this study
Official title: Comparing the Effectiveness of Blood Flow Restriction Therapy Versus Standard Exercise After Arthroscopic Rotator Cuff Repair: Protocol for the Multicenter S-TRONGER Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of postoperative standard exercises with blood flow restriction therapy (BFRT) versus standard exercises alone on shoulder muscle strength and mass in participants with surgically treated rotator cuff tear. It is presumed that the addition of BFRT will significantly improve the shoulder strength and muscle mass at the end of the intervention period compared to the group receiving only standard exercises.
Patients who agree to participate in this research will be randomly assigned to a control group (standard exercises alone) or an experimental group (standard rehabilitation with BFRT). The duration of the postoperative intervention will be 12 weeks. The primary variables will be the shoulder muscle strength and muscle mass. Secondary variables will be the active shoulder mobility, pain intensity, upper limb disability, and health-related quality of life. Results will be measured at 0, 4 and 12 weeks postoperative.
- Conditions
- Rotator Cuff Injury, Rotator Cuff Tears, Rotator Cuff Repair
- Being tested
- Standard rehabilitation, Blood Flow Restriction Therapy
- Keywords
- blood flow restriction therapy, blood flow restriction training
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabilitationOther
Protocol based on the best available evidence and to be used in all participants in both groups. The standard exercises protocol will consist of three postoperative rehabilitation phases: phase I (weeks 1 to 4), phase II (weeks 5 to 8) and phase III (weeks 9 to 12). Sessions will be held 2 times a week for 12 weeks. Each session will last 45 minutes and will consist of six exercises in the phase I, eight exercises in phase II, and eight exercises in phase III.
Blood Flow Restriction TherapyDevice
Participants will perform three exercises of the standard exercises protocol with BFRT. An auto-regulated portable BFRT SmartCuffs® 3.0 Pro system with a 17-inch long and 5-inch-wide cuff (Smart Tools Plus, United States), placed on the most proximal part of the arm, will be used. Each BFRT session will begin with a maximal occlusion test to personalize the occlusion pressure to the participant. The limb occlusion pressure (LOP) will be set at 50% of the maximum occlusion pressure in the first stage and 60% in stages II and III. The participant will perform 75 repetitions per BFRT exercise divided into 4 sets (30, 15, 15, and 15 repetitions). The load intensity during the BFRT exercises will be set near to 3 out of 10 on the Borg's CR10 scale ("weak"), which corresponds to 30% of a 1RM effort. After each exercise, the cuff will be deflated, and the patient will rest for two minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standard exercises with BFRT | Experimental | Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises with BFRT during the three phases of standard rehabilitation. Receives: Other: Standard rehabilitation; Device: Blood Flow Restriction Therapy |
| Standard exercises alone | Active comparator | Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises without BFRT during the three phases of standard rehabilitation. Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder muscle strength
Shoulder abduction and external rotation maximum voluntary isometric strength will be measured using dynamometry (kilograms)
Measured: 0, 4 and 12 weeks
Shoulder muscle mass
Supraspinatus and long head biceps brachii tendon thickness will be measured using ultrasound imaging (milimeters)
Measured: 0, 4 and 12 weeks
Secondary outcomes (4)
Active Range of Motion
Shoulder flexion, abduction, and external rotation will be measured with a goniometer (degrees)
Measured: 0, 4 and 12 weeks
Pain intensity
Visual Analogue Scale (0 to 10 centimeters)
Measured: 0, 4 and 12 weeks
Self-reported upper limb disability
Shoulder Pain Disability Index (0 to 100%)
Measured: 0, 4 and 12 weeks
Self-reported quality of life
Western Ontario Rotator Cuff Index (0 to 100%)
Measured: 0, 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start3 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuryStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Casaña Granell, University of Valencia
- Investigators
- Felipe Ponce-Fuentes, MSc, Principal investigator, Universidad Mayor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788327
- Sponsor's protocol ID
- BFRT in RCR rehabilitation
- Acronym
- S-TRONGER
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
PubMed 31156448Lambert BS, Hedt C, Ankersen JP, Goble H, Taft C, Daum J, Karasch R, Moreno MR, McCulloch PC. Rotator cuff training with upper extremity blood flow restriction produces favorable adaptations in division IA collegiate pitchers: a randomized trial. J Shoulder Elbow Surg. 2023 Jun;32(6):e279-e292. doi: 10.1016/j.jse.2023.02.116. Epub 2023 Mar 17.
PubMed 36933646Lambert B, Hedt C, Daum J, Taft C, Chaliki K, Epner E, McCulloch P. Blood Flow Restriction Training for the Shoulder: A Case for Proximal Benefit. Am J Sports Med. 2021 Aug;49(10):2716-2728. doi: 10.1177/03635465211017524. Epub 2021 Jun 10.
PubMed 34110960Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
PubMed 33471547Kara D, Ozcakar L, Demirci S, Huri G, Duzgun I. Blood Flow Restriction Training in Patients With Rotator Cuff Tendinopathy: A Randomized, Assessor-Blinded, Controlled Trial. Clin J Sport Med. 2024 Jan 1;34(1):10-16. doi: 10.1097/JSM.0000000000001191. Epub 2023 Sep 14.
PubMed 37706671Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27.
PubMed 32105522Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. J Shoulder Elbow Surg. 2020 Jun;29(6):1267-1274. doi: 10.1016/j.jse.2020.02.003.
PubMed 32423577
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Blood Flow Restriction Therapy Versus Standard Exercise After Arthroscopic Rotator Cuff Repair: Protocol for the Multicenter S-TRONGER Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06788327
- Acronym / sponsor ID
- S-TRONGER / BFRT in RCR rehabilitation
- Conditions
- Rotator Cuff Injury, Rotator Cuff Tears, Rotator Cuff Repair
- Keywords
- blood flow restriction therapy, blood flow restriction training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 3 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 23 Jan 2025 (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.
The goal of this clinical trial is to determine the effectiveness of postoperative standard exercises with blood flow restriction therapy (BFRT) versus standard exercises alone on shoulder muscle strength and mass in participants with surgically treated rotator cuff tear. It is presumed that the addition of BFRT will significantly improve the shoulder strength and muscle mass at the end of the intervention period compared to the group receiving only standard exercises.
Patients who agree to participate in this research will be randomly assigned to a control group (standard exercises alone) or an experimental group (standard rehabilitation with BFRT). The duration of the postoperative intervention will be 12 weeks. The primary variables will be the shoulder muscle strength and muscle mass. Secondary variables will be the active shoulder mobility, pain intensity, upper limb disability, and health-related quality of life. Results will be measured at 0, 4 and 12 weeks postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard exercises with BFRT | Experimental | Other: Standard rehabilitation, Device: Blood Flow Restriction TherapyParticipants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises with BFRT during the three phases of standard rehabilitation. |
| Standard exercises alone | Active comparator | Other: Standard rehabilitationParticipants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises without BFRT during the three phases of standard rehabilitation. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 40-65 years
- Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging
- Undergoing arthroscopic rotator cuff repair
- Be able to read and understand Spanish
Key exclusion criteria (9 listed)
- Massive irreparable rotator cuff tear
- Concomitant fracture
- Labral or nerve injury
- Suspicious of developing a frozen shoulder
- Revision surgery after rotator cuff repair
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 |
|---|---|---|
| Standard rehabilitationProtocol based on the best available evidence and to be used in all participants in both groups. The standard exercises protocol will consist of three postoperative rehabilitation phases: phase I (weeks 1 to 4), phase II (weeks 5 to 8) and phase III (weeks 9 to 12). Sessions will be held 2 times a week for 12 weeks. Each session will last 45 minutes and will consist of six exercises in the phase I, eight exercises in phase II, and eight exercises in phase III. | Other | Standard exercises alone, Standard exercises with BFRT |
| Blood Flow Restriction TherapyParticipants will perform three exercises of the standard exercises protocol with BFRT. An auto-regulated portable BFRT SmartCuffs® 3.0 Pro system with a 17-inch long and 5-inch-wide cuff (Smart Tools Plus, United States), placed on the most proximal part of the arm, will be used. Each BFRT session will begin with a maximal occlusion test to personalize the occlusion pressure to the participant. The limb occlusion pressure (LOP) will be set at 50% of the maximum occlusion pressure in the first stage and 60% in stages II and III. The participant will perform 75 repetitions per BFRT exercise divided into 4 sets (30, 15, 15, and 15 repetitions). The load intensity during the BFRT exercises will be set near to 3 out of 10 on the Borg's CR10 scale ("weak"), which corresponds to 30% of a 1RM effort. After each exercise, the cuff will be deflated, and the patient will rest for two minutes. | Device | Standard exercises with BFRT |
Primary outcome
Shoulder muscle strength
Time frame: 0, 4 and 12 weeks
Shoulder abduction and external rotation maximum voluntary isometric strength will be measured using dynamometry (kilograms)
Shoulder muscle mass
Time frame: 0, 4 and 12 weeks
Supraspinatus and long head biceps brachii tendon thickness will be measured using ultrasound imaging (milimeters)
4 secondary outcomes
Active Range of Motion
Time frame: 0, 4 and 12 weeks
Pain intensity
Time frame: 0, 4 and 12 weeks
Self-reported upper limb disability
Time frame: 0, 4 and 12 weeks
Self-reported quality of life
Time frame: 0, 4 and 12 weeks
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 23 Jan 2025.
- Background: PubMed 31156448Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
- Background: PubMed 36933646Lambert BS, Hedt C, Ankersen JP, Goble H, Taft C, Daum J, Karasch R, Moreno MR, McCulloch PC. Rotator cuff training with upper extremity blood flow restriction produces favorable adaptations in division IA collegiate pitchers: a randomized trial. J Shoulder Elbow Surg. 2023 Jun;32(6):e279-e292. doi: 10.1016/j.jse.2023.02.116. Epub 2023 Mar 17.
- Background: PubMed 34110960Lambert B, Hedt C, Daum J, Taft C, Chaliki K, Epner E, McCulloch P. Blood Flow Restriction Training for the Shoulder: A Case for Proximal Benefit. Am J Sports Med. 2021 Aug;49(10):2716-2728. doi: 10.1177/03635465211017524. Epub 2021 Jun 10.
- Background: PubMed 33471547Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
- Background: PubMed 37706671Kara D, Ozcakar L, Demirci S, Huri G, Duzgun I. Blood Flow Restriction Training in Patients With Rotator Cuff Tendinopathy: A Randomized, Assessor-Blinded, Controlled Trial. Clin J Sport Med. 2024 Jan 1;34(1):10-16. doi: 10.1097/JSM.0000000000001191. Epub 2023 Sep 14.
- Background: PubMed 32105522Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27.
- Background: PubMed 32423577Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. J Shoulder Elbow Surg. 2020 Jun;29(6):1267-1274. doi: 10.1016/j.jse.2020.02.003.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Injury
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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.
Felipe Ponce-Fuentes, MSc principal investigator
Universidad Mayor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard rehabilitation and Blood Flow Restriction Therapy in people with Rotator Cuff Injury and Rotator Cuff Tears, run by University of Valencia at 1 site in Chile.
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 4 inclusion and 9 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 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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 José Casaña, PhD (+34656437371, jose.casana@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder muscle strength (time frame: 0, 4 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788327, which also lists 7 linked publications.
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 23 Jan 2025.