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NCT Number: NCT06788327

Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica RedSalud Mayor

Temuco, Cautín, 4800580, Chile

Location contact

Daniela Mansilla

CONTACT

[email protected]

+56996521664

Felipe Ponce-Fuentes, MSc

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Active Range of Motion

    Time frame: 0, 4 and 12 weeks

    Shoulder flexion, abduction, and external rotation will be measured with a goniometer (degrees)

  2. Pain intensity

    Time frame: 0, 4 and 12 weeks

    Visual Analogue Scale (0 to 10 centimeters)

  3. Self-reported upper limb disability

    Time frame: 0, 4 and 12 weeks

    Shoulder Pain Disability Index (0 to 100%)

  4. Self-reported quality of life

    Time frame: 0, 4 and 12 weeks

    Western Ontario Rotator Cuff Index (0 to 100%)

Study contacts

Contact information is provided by the study sponsor or research team.

Felipe Ponce-Fuentes, MSc

CONTACT

[email protected]

+56954411974

José Casaña, PhD

CONTACT

[email protected]

+34656437371

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study 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

Acronym: S-TRONGER

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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