Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery

NCT ID: NCT07131787

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2028-11-30

Brief Summary

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

Conditions

Achilles Tendon Rupture; Blood Flow Restriction Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional therapy

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

Group Type: ACTIVE_COMPARATOR

Standardised strength training

Intervention Type: OTHER

This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.

Blood flow restriction group

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.

Group Type: EXPERIMENTAL

Blood flow restriction training (smart-cuff pro device)

Intervention Type: DEVICE

This group will undergo low load strength training consisting of calf, thigh, glute and core exercises. A Blood flow restriction cuff will be added during selected exercises in rehabilitation program (targeting quadriceps and calf muscles)

Interventions

Blood flow restriction training (smart-cuff pro device)

This group will undergo low load strength training consisting of calf, thigh, glute and core exercises. A Blood flow restriction cuff will be added during selected exercises in rehabilitation program (targeting quadriceps and calf muscles)

Intervention Type: DEVICE

Standardised strength training

This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.

Intervention Type: OTHER

Other Intervention Names

Kaatsu; Partial vascular occlusion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arne Burssens, Professor

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Ghent University

Ghent, East-Flanders, Belgium

Site Status: NOT_YET_RECRUITING

Ghent University Hospital

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Sarah VanDen Berghe

Role: CONTACT

sarah.vandenberghe@ugent.be

+32471178728

Facility Contacts

Sarah VanDen Berghe, MSc

Role: primary

sarah.vandenberghe@ugent.be

+32471178728

Arne Burssens, Prof. Dr.

Role: primary

arne.burssens@ugent.be

+32 9 332 22 51

Other Identifiers

ONZ-2025-0152

Identifier Type: -

Identifier Source: org_study_id