Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery (TENDON-BFR)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Achilles Tendon Rupture; Blood Flow Restriction Therapy

Treatments: Other: Standardised strength training; Device: Blood flow restriction training (smart-cuff pro device)

Study type: Interventional

Funder types: Other

Identifiers

NCT07131787

ONZ-2025-0152

Details and patient eligibility

About

The goal of this clinical trial is to investigate whether rehabilitation with blood flow restriction (BFR) offers added value compared to conventional rehabilitation in patients undergoing surgical repair for Achilles tendon rupture. The study will include adult patients of all sexes who have undergone surgical treatment at two selected hospitals.

The main questions it aims to answer are:

Does BFR-enhanced rehabilitation improve functional recovery compared to conventional rehabilitation? What are the effects of BFR on muscle strength and tendon recovery?

Researchers will compare blood flow restriction (BFR) therapy with conventional rehabilitation to determine whether BFR leads to improved clinical, muscular, and tendon-related outcomes.

Participants will:

1. Undergo standard surgical repair of the Achilles tendon

2. Be randomly assigned to a 24-week exercise therapy program-either with or without blood flow restriction (BFR)-starting four weeks post-surgery

3. Take part in follow-up assessments at weeks 4, 8, 12, 18, 24, and 52, which will include:

   • Questionnaires on pain, quality of life, fear of movement, and return to sport
   • Medical imaging techniques such as ultrasound, MRI, shear wave elastography, and power Doppler
   • Muscle strength testing
   • Blood sample collection, along with a tendon tissue sample taken during surgery

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with total midrupture Achilles tendon rupture
• surgical treatment
• > 18 years old
• able to understand and speak Dutch

Exclusion criteria

• Bilateral Achilles tendon rupture
• Previous Achilles tendon rupture
• Previous treatment with fluoroquinolones or cortisone
• other condition in either leg that would limit the ability to perform the exercises or evaluations
• Diabetes or rheumatic diseases
• History of deep venous thrombosis
• severe cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Conventional therapy

Active Comparator group

Description:

control group: patients in this group will undergo the same standard strength training program as the BFR-group, but without a tourniquet.

Treatment:

Other: Standardised strength training

Blood flow restriction group

Experimental group

Description:

patients in this group will undergo a standard strength training program combined with an occlusion cuff. The cuff will be used during exercises targeting quadriceps and calf muscles.

Treatment:

Device: Blood flow restriction training (smart-cuff pro device)