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NCT06434272
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Conditions: Achilles Tendon Rupture
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 218
Sponsor: University of Aarhus
Location: Aarhus University Hospital Aarhus N Denmark
Summary
The goal of this clinical trial is to gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture. The main questions it aims to answer are:
Is BFRE an effective adjunct to usual care when compared with only usual care? When is the optimal timing for initiating BFRE: In the early treatment stage or at the later stage after hospital treatment? Participants will receive an intervention comprising 12 weeks of BFRE as an adjunct to usual care.
* Either in the initial 1-12 weeks after Achilles tendon rupture, or
* In the following 13-24 weeks after Achilles tendon rupture
Researchers will compare the two groups at 13 weeks (3 months) to compare BFRE to usual care, and at 25 weeks (6 months) to compare the two time points for initiating BFRE (early vs. late).
Eligibility 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.)
Source: ClinicalTrials.gov (NCT06434272). StuddyBuddy aggregates publicly available trial information.