Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture

NCT06434272 | Recruiting DMC

• 1 other identifier: BEAN (1-10-72-192-23)
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (2)

• Single-leg heel-rise test

  Patient's ability to perform a Single-Leg Heel-rise, defined as the ability to raise the heel of the injured leg at least 2 cm while keeping the knee straight. The test is performed with patients standing on a flat surface with the ankle in a neutral position. Patients will be allowed to keep their balance by lightly touching a wall.

  Primary outcome at 13 week test. Measured as a secondary outcome at 25 week test.

• Achilles tendon Total Rupture Score (ATRS)

  The ATRS is a validated patient-reported, injury-specific questionnaire regarding physical activity and symptoms. The ATRS consists of 10 items scored from 0 (major limitations) to 10 (no limitations), resulting in a score between 0 (worst) to 100 (best).

  Primary outcome at 25 week test. It is also measured at baseline through recall of the pre-injury condition and at the 13 week test as a secondary outcome.

Secondary Outcomes (9)

• 30 seconds unilateral Sit to Stand test

  The test will be performed on both legs at 13 week test and 25 test.

• Calf circumference

  The measurement will be performed on both legs at 13 week test and 25 test.

• Thigh circumference

  The measurement will be performed on both legs at 13 week test and 25 test.

• Achilles tendon elongation (ATRA)

  The test will be performed on both legs at 13 week test and 25 test.

• Single-leg heel-rise height

  The test will be performed on both legs at 13 week test and 25 week test.

Other Outcomes (8)

• Patient Acceptable Symptom State (PASS)

  Measured at 25 week test.

• Global rating of change

  Measured at 13 week test and 25 week test.

• Exercise adherence and progression

  Measured continously, and evaluated at 13 week test and 25 week test.

Study Arms (2)

Early initiated Blood Flow Restriction Exercise

EXPERIMENTAL

Receives an intervention in adjunct to usual care in weeks 1-12, and continues with usual care in weeks 13-24.

Other: Early exercise with partial Blood Flow Restriction

Late initiated Blood Flow Restriction Exercise

EXPERIMENTAL

Receives usual care in weeks 1-12, and receives an intervention in adjunct to usual care weeks 13-24.

Other: Late exercise with partial Blood Flow Restriction

Interventions

Early exercise with partial Blood Flow Restriction OTHER

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.

Also known as: BFR, BFRE, Blood Flow Restriction Exercise, BFR-T, Blood Floow Restriciton Training, LL-BFR, Low Load Blood Flow Restriction

Early initiated Blood Flow Restriction Exercise

Late exercise with partial Blood Flow Restriction OTHER

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.

Also known as: BFR, BFRE, Blood Flow Restriction Exercise, BFR-T, Blood Flow Restriction Training, LL-BFR, Low Load Blood Flow Restriction

Late initiated Blood Flow Restriction Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Gødstrup Hospital: collaborator
• Regionshospitalet Horsens: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Andreas Bentzen, MHSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, DMSc

  University of Aarhus

  STUDY DIRECTOR

• Per H. Gundtoft, MD, PhD

  Aarhus University Hospital

  STUDY DIRECTOR

• Stian L. Jørgensen, PT, PhD

  Regionshospitalet Horsens

  STUDY DIRECTOR

Central Study Contacts

Andreas Bentzen, MHSc

CONTACT

4553109112; andreas.bentzen@clin.au.dk

Inger Mechlenburg, DMSc

CONTACT

4521679062; inger.mechlenburg@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): January 9, 2028
• Study Completion (Estimated): January 9, 2028
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after publication of the trial.
• Access Criteria: Data access will be reviewed by the author group. Requesters will be required to sign a data access agreement.

Locations

DK (1)