Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients Wi… (NCT07498166) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair
United States75 participantsStarted 2026-02-01
Plain-language summary
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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Adults aged 18 to 75 years
* Acute unilateral midportion Achilles tendon rupture
* Primary surgical repair performed within 2 weeks of injury
* Willingness and ability to comply with the postoperative rehabilitation protocol and follow-up schedule
Exclusion Criteria:
* Cognitive impairment or inability to follow study instructions
* Planned postoperative follow-up at another institution
* Use of fluoroquinolone antibiotics or systemic corticosteroids within the past 6 months
* Previous Achilles tendon rupture in either limb
* Simultaneous bilateral Achilles tendon rupture
* History of venous thromboembolism (deep venous thrombosis or pulmonary embolism)
* Diabetes mellitus
* Reduced lower extremity function due to conditions other than Achilles tendon rupture
* Uncontrolled hypertension
* Peripheral vascular disease or ankle-brachial index less than 1.0
* Chronic kidney disease or heart failure with lower extremity edema
* Lower extremity dialysis access
* Lower extremity thrombophlebitis
* Active cancer or ongoing chemotherapy treatment
* Prior lymphadenectomy
* Tumor or malignancy affecting the lower extremities
* Hemophilia or other major bleeding disorders
* Factor V Leiden mutation or known thrombophilia
* Sickle cell anemia
* Pregnancy
* Surgery within the previous month
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.