Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair

Официальное название

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

Обзор

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.

Вмешательства

• Другое Standard rehabilitation
  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.
• Устройство Blood Flow Restriction Therapy
  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 s

Первичные конечные точки

• Shoulder muscle strength [Срок оценки: 0, 4 and 12 weeks]
• Shoulder muscle mass [Срок оценки: 0, 4 and 12 weeks]

Вторичные конечные точки (4)

• Active Range of Motion [Срок оценки: 0, 4 and 12 weeks]
• Pain intensity [Срок оценки: 0, 4 and 12 weeks]
• Self-reported upper limb disability [Срок оценки: 0, 4 and 12 weeks]
• Self-reported quality of life [Срок оценки: 0, 4 and 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Clínica RedSalud Mayor — Temuco

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06788327 · BFRT in RCR rehabilitation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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