Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Participants receive standard postoperative Achilles tendon rehabilitation combined with blood flow restriction resistance training using the Delfi Personalized Tourniquet System. Cuffs are calibrated to 80% limb occlusion pressure to induce controlled vascular restriction during low-load resistance exercises. All sessions are supervised by trained physiotherapists following the standardized Massachusetts General Hospital Achilles rehabilitation protocol.
Participants undergo the standardized Massachusetts General Hospital postoperative Achilles tendon rehabilitation program including range-of-motion exercises, progressive strengthening, and return-to-sport phases. No blood flow restriction device is used during rehabilitation sessions.
Participants receive the same standardized postoperative rehabilitation protocol while wearing Delfi tourniquet cuffs inflated to 20 mmHg, a pressure insufficient to induce blood flow restriction. This sham condition controls for potential placebo effects associated with the device while maintaining identical exercise protocols and therapist supervision.
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Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
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