Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair

The goal of this clinical trial is to determine whether blood flow restriction resistance training (BFR-RT) improves postoperative muscle recovery and functional outcomes following primary surgical repair of acute Achilles tendon rupture (ATR) in adults undergoing standard rehabilitation. The main questions it aims to answer are: Does patient-specific BFR-RT improve ankle plantarflexion strength recovery compared with sham BFR-RT or standard rehabilitation alone? Does BFR-RT improve gastrocnemius-soleus muscle morphology and patient-reported functional outcomes following ATR repair? Researchers will compare (1) BFR-RT combined with standard physical therapy, (2) sham BFR-RT combined with standard physical therapy, and (3) standard physical therapy alone to determine whether BFR-RT enhances muscle recovery, functional outcomes, and return-to-activity timelines following surgical ATR repair. Participants will: Be randomized to BFR-RT + standard physical therapy, sham BFR-RT + standard physical therapy, or standard physical therapy alone Perform supervised rehabilitation exercises using a personalized tourniquet system calibrated to limb occlusion pressure (LOP) depending on group allocation Undergo isometric ankle plantarflexion strength testing using the Fysiometer platform Receive ultrasound imaging of the gastrocnemius-soleus complex to assess muscle cross-sectional area Complete patient-reported outcome measures assessing pain and physical function Attend follow-up evaluations at 6 weeks, 3 months, 4.5 months, 6 months, and 12 months postoperatively

NCT Number	NCT07498166
Lead Sponsor	Massachusetts General Hospital
Conditions	Achilles Tendon Rupture, Blood Flow Restriction Therapy, Achilles Tendon Repairs/Reconstructions, Dynamic Blood Flow Restriction
Enrollment	75 participants
Start Date	2026-02-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-01