Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard rehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder muscle strength | Shoulder abduction and external rotation maximum voluntary isometric strength will be measured using dynamometry (kilograms) | 0, 4 and 12 weeks |
| Shoulder muscle mass | Supraspinatus and long head biceps brachii tendon thickness will be measured using ultrasound imaging (milimeters) | 0, 4 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Active Range of Motion | Shoulder flexion, abduction, and external rotation will be measured with a goniometer (degrees) | 0, 4 and 12 weeks |
| Pain intensity | Visual Analogue Scale (0 to 10 centimeters) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Casaña, PhD | Contact | +34656437371 | jose.casana@uv.es | |
| Felipe Ponce-Fuentes, MSc | Contact | +56954411974 | felipe.poncef@umayor.cl |
| Name | Affiliation | Role |
|---|---|---|
| Felipe Ponce-Fuentes, MSc | Universidad Mayor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica RedSalud Mayor | Temuco | Cautín | 4800580 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31156448 | Background | 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. | |
| 36933646 |
| Label | URL |
|---|---|
| Ponce-Fuentes, F., Cuyul-Vásquez, I., Carranza, J., Lluch, E., Calatayud, J., Casaña, J., ... \& Struyf, F. (2024). Early Rehabilitation With Blood Flow Restriction Therapy Following Arthroscopic Rotator Cuff Repair: A Case Report. JOSPT Cases, 4(3) | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Opaque sealed envelopes
|
| Blood Flow Restriction Therapy | Device | 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. |
|
| 0, 4 and 12 weeks |
| Self-reported upper limb disability | Shoulder Pain Disability Index (0 to 100%) | 0, 4 and 12 weeks |
| Self-reported quality of life | Western Ontario Rotator Cuff Index (0 to 100%) | 0, 4 and 12 weeks |
| Lambert 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. |
| 34110960 | Background | Lambert 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. |
| 33471547 | Background | Kjaer 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. |
| 37706671 | Background | Kara 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. |
| 32105522 | Background | Hughes 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. |
| 32423577 | Background | Bowman 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. |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |