Blood Flow Restriction Exercise for Achilles Tendon Rupture
The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically
This study is testing if adding Blood Flow Restriction Exercise to regular treatment can help people recover better from an Achilles tendon rupture, depending on when they start the exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT06434272 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Blood Flow Restriction Exercise (BFRE) as an adjunct to usual care in patients with an acute Achilles tendon rupture. Participants will be randomly assigned to receive BFRE either in the early phase (1-12 weeks) or later phase (13-24 weeks) after their injury, alongside standard treatment. The study aims to determine the effectiveness of BFRE compared to usual care alone and to identify the optimal timing for initiating BFRE. Outcome measures will include functional tests and self-reported symptoms assessed at 13 and 25 weeks post-allocation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have sustained an acute Achilles tendon rupture and can start treatment within 72 hours.
Not a fit: Patients with bilateral Achilles tendon ruptures or significant comorbidities affecting lower extremity function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and functional outcomes for patients with Achilles tendon ruptures.
How similar studies have performed: While the use of BFRE is gaining attention, this specific application in Achilles tendon rupture is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18 years or older * have started initial treatment within 72 hours of Achilles tendon rupture * understand written and spoken Danish Exclusion Criteria: * bilateral Achilles tendon rupture * previous Achilles tendon rupture in either leg * decreased lower extremity function, caused by conditions other than Achilles tendon rupture * treated with fluoroquinolones within the last six months * treated with corticosteroid injection(s) in the area near the Achilles tendon within the last six months. * diabetes * previous diagnosed thrombosis * Known atherosclerosis in the peripheral arteries of the lower limb * other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.)
Where this trial is running
Aarhus N
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Principal investigator: Andreas Bentzen, MHSc — University of Aarhus
- Study coordinator: Andreas Bentzen, MHSc
- Email: andreas.bentzen@clin.au.dk
- Phone: 4553109112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.