Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair

NCT06788327 | Not Yet Recruiting DMC

• 1 other identifier: BFRT in RCR rehabilitation
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

blood flow restriction therapy; blood flow restriction training

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Active Range of Motion

  0, 4 and 12 weeks

• Pain intensity

  0, 4 and 12 weeks

• Self-reported upper limb disability

  0, 4 and 12 weeks

• Self-reported quality of life

  0, 4 and 12 weeks

Study Arms (2)

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.

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.

Other: Standard rehabilitation

Interventions

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.

Standard exercises alone; Standard exercises with BFRT

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.

Standard exercises with BFRT

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Clínica RedSalud Mayor

Temuco, Cautín, 4800580, Chile

Location

Related Publications (7)

• 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.

  PMID: 31156448 BACKGROUND

• 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.

  PMID: 36933646 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.

  PMID: 34110960 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.

  PMID: 33471547 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.

  PMID: 37706671 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.

  PMID: 32105522 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.

  PMID: 32423577 BACKGROUND

Related Links

• 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)

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Felipe Ponce-Fuentes, MSc

  Universidad Mayor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Casaña, PhD

CONTACT

+34656437371; jose.casana@uv.es

Felipe Ponce-Fuentes, MSc

CONTACT

+56954411974; felipe.poncef@umayor.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Opaque sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 23, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)