Clínica RedSalud Mayor
Temuco, Cautín, 4800580, Chile
NCT Number: NCT06788327
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.
Trial opening soon.
Get Notified40 year–65 year
All sexes
Interventional
Not applicable
Temuco, Cautín, 4800580, Chile
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 0, 4 and 12 weeks
Shoulder abduction and external rotation maximum voluntary isometric strength will be measured using dynamometry (kilograms)
Time frame: 0, 4 and 12 weeks
Supraspinatus and long head biceps brachii tendon thickness will be measured using ultrasound imaging (milimeters)
Time frame: 0, 4 and 12 weeks
Shoulder flexion, abduction, and external rotation will be measured with a goniometer (degrees)
Time frame: 0, 4 and 12 weeks
Visual Analogue Scale (0 to 10 centimeters)
Time frame: 0, 4 and 12 weeks
Shoulder Pain Disability Index (0 to 100%)
Time frame: 0, 4 and 12 weeks
Western Ontario Rotator Cuff Index (0 to 100%)
Contact information is provided by the study sponsor or research team.
Felipe Ponce-Fuentes, MSc
CONTACT
José Casaña, PhD
CONTACT
University of Valencia
Other
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
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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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