RecruitingNot ApplicableNCT06434272

Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture

The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically

Sponsor

University of Aarhus

Enrollment

218 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Achilles Tendon Rupture

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

Min Age: 18 Years

Inclusion Criteria3

aged 18 years or older
have started initial treatment within 72 hours of Achilles tendon rupture
understand written and spoken Danish

Exclusion Criteria9

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.)

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Interventions

OTHEREarly exercise with partial Blood Flow Restriction

The intervention comprises of 12 weeks of blood flow restriction exercise in weeks 1-12 after injury. Three weekly exercise sessions are performed. Six supervised sessions are provided during the 12 weeks. Blood flow restriction of 80% of the limb occlusion pressure required to fully restrict the arterial blood flow is employed. The intervention comprises three exercises: Seated leg extension, standing knee flexion, and seated heel-rise performed at home as an adjunct to usual care treatment. Each exercise is performed in four sets of 30, 15, 15, +1 repetitions, with the fourth set (+1) being as many repetitions as possible. Pause in between sets is 30 seconds. Pause in between exercises are 120 seconds. In weeks 13-24, patients in this arm follow usual care treatment.

OTHERLate exercise with partial Blood Flow Restriction

The intervention comprises of 12 weeks of blood flow restriction exercise in weeks 13-24 after injury. Three weekly exercise sessions are performed. Six supervised sessions are provided during the 12 weeks. Blood flow restriction of 80% of the limb occlusion pressure required to fully restrict the arterial blood flow is employed. The intervention comprises three exercises: Leg press in machine, heel-rise in machine, knee flexion in machine performed at training facilities as an adjunct to usual care treatment. If facilities are unavailable, three home-based exercises will be provided. Each exercise, regardless of study arm, is performed in four sets of 30, 15, 15, +1 repetitions, with the fourth set (+1) being as many repetitions as possible. In weeks 1-12, patients in this arm follow usual care treatment.