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NCT07498166 · ClinicalTrials.gov registry record · NA
Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair
A NA study, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT07498166: Active NA study, sponsored by Massachusetts General Hospital.
NCT07498166 is a NA study that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07498166, a NA study, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study 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
Primary Outcome
The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome instrument used to assess symptoms and physical function following Achilles tendon rupture. The score ranges from 0 to 100, with higher scores indicating better function and fewer symptoms.
Interventions
- DEVICE Blood Flow Restriction Resistance Training (BFR-RT)
- DEVICE Sham Blood Flow Restriction
- BEHAVIORAL Standard Physical Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2026-02-01 |
| Est. Completion | 2027-02-01 |
| Phase | NA |
What the registry record for NCT07498166 still lists
NCT07498166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Blood Flow Restriction Resistance Training (BFR-RT) is the first listed.
NCT07498166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07498166 about?
NCT07498166 is a clinical study titled "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 q...
What is the current status of trial NCT07498166?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 75 participants. The study started on 2026-02-01. Estimated completion is 2027-02-01.
What interventions are being tested in trial NCT07498166?
The interventions under investigation include: Blood Flow Restriction Resistance Training (BFR-RT) (DEVICE), Sham Blood Flow Restriction (DEVICE), Standard Physical Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT07498166?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07498166's enrollment target sits among peer trials
75 1069th of 2000 higher than 919 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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