Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair

NANot yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 3, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

August 31, 2027

Conditions
Rotator Cuff InjuryRotator Cuff TearsRotator Cuff Repair
Interventions
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."

Trial Locations (1)

4800580

Clínica RedSalud Mayor, Temuco

All Listed Sponsors
lead

University of Valencia

OTHER

NCT06788327 - Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair | Biotech Hunter | Biotech Hunter