Health TrialsbyHealthPanel

Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair

ConditionsRotator Cuff InjuryRotator Cuff TearsRotator Cuff Repair
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Valencia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Massive irreparable rotator cuff tear

Concomitant fracture

Labral or nerve injury

Suspicious of developing a frozen shoulder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard rehabilitation

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard exercises with BFRTExperimental treatment 2 interventions
Group B: Standard exercises aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Shoulder muscle strength

Shoulder abduction and external rotation maximum voluntary isometric strength will be measured using dynamometry (kilograms)

Time frame
0, 4 and 12 weeks
2

Shoulder muscle mass

Supraspinatus and long head biceps brachii tendon thickness will be measured using ultrasound imaging (milimeters)

Time frame
0, 4 and 12 weeks

Secondary outcomes

1

Active Range of Motion

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

Time frame
0, 4 and 12 weeks
2

Pain intensity

Visual Analogue Scale (0 to 10 centimeters)

Time frame
0, 4 and 12 weeks
3

Self-reported upper limb disability

Shoulder Pain Disability Index (0 to 100%)

Time frame
0, 4 and 12 weeks
4

Self-reported quality of life

Western Ontario Rotator Cuff Index (0 to 100%)

Time frame
0, 4 and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Valencia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: