Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair (S-TRONGER)

January 16, 2025 updated by: José Casaña Granell, University of Valencia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
    • Cautín
      • Temuco, Cautín, Chile, 4800580
        • Clínica RedSalud Mayor
        • Contact:
        • Contact:
          • Felipe Ponce-Fuentes, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard exercises with BFRT
Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises with BFRT during the three phases of standard rehabilitation.
Other: 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.
Device: 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 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.
Active Comparator: Standard exercises alone
Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises without BFRT during the three phases of standard rehabilitation.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0, 4 and 12 weeks
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)
0, 4 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active Range of Motion
Time Frame: 0, 4 and 12 weeks
Shoulder flexion, abduction, and external rotation will be measured with a goniometer (degrees)
0, 4 and 12 weeks
Pain intensity
Time Frame: 0, 4 and 12 weeks
Visual Analogue Scale (0 to 10 centimeters)
0, 4 and 12 weeks
Self-reported upper limb disability
Time Frame: 0, 4 and 12 weeks
Shoulder Pain Disability Index (0 to 100%)
0, 4 and 12 weeks
Self-reported quality of life
Time Frame: 0, 4 and 12 weeks
Western Ontario Rotator Cuff Index (0 to 100%)
0, 4 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Felipe Ponce-Fuentes, MSc, Universidad Mayor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFRT in RCR rehabilitation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotator Cuff Repair

Clinical Trials on Standard rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe