Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06434272

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

Led by University of Aarhus · Updated on 2025-04-17

218

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon rupture treated without surgery. The study aims to determine if BFRE is an effective addition to usual care and to find the best timing for starting BFRE—either early (within 1-12 weeks after injury) or later (13-24 weeks after injury). This is a randomized, assessor-blinded trial comparing these two approaches with follow-ups at 13 and 25 weeks. Participants are assigned to one of two groups: one group receives BFRE alongside usual care during weeks 1-12 after injury and then continues usual care alone, while the other group receives usual care alone for the first 12 weeks and adds BFRE during weeks 13-24. The BFRE program involves three weekly sessions using 80% limb occlusion pressure to partially restrict blood flow, with exercises such as leg extensions, knee flexion, and heel-rise performed either at home or in training facilities, supervised six times over 12 weeks. During the study, participants are assessed at baseline, 13 weeks, and 25 weeks using tests like the Single-Leg Heel-Rise test and the Achilles Total Tendon Rupture Score to measure physical function and symptoms. Additional evaluations include muscle circumference, endurance, physical activity questionnaires, and monitoring for adverse events. Usual care involves ankle immobilization and gradual weight bearing early on, transitioning to home or facility-based exercises later. The total participation duration covers up to 25 weeks after allocation.

CONDITIONS

Brief Title

Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Started initial treatment within 72 hours of Achilles tendon rupture
  • Understand written and spoken Danish
Not Eligible

You will not qualify if you...

  • Bilateral Achilles tendon rupture
  • Previous Achilles tendon rupture in either leg
  • Decreased lower extremity function from other causes than Achilles tendon rupture
  • Treatment with fluoroquinolones within the last six months
  • Corticosteroid injections near the Achilles tendon in the last six months
  • Diabetes
  • Previously diagnosed thrombosis
  • Known atherosclerosis in peripheral arteries of the lower limb
  • Other exclusion reasons such as cognitive deficits, inability to consent, or need for cast treatment due to low compliance

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive a 12-week blood flow restriction exercise program as an add-on to usual care. One group performs the program in weeks 1 to 12 post allocation, and the other group performs it in weeks 13 to 24 post allocation. Exercises are performed three times weekly with six supervised sessions during the 12 weeks.

Three weekly exercise sessions with six supervised visits during the 12 weeks

Follow-up

Duration - Up to 12 weeks after treatment

Participants are assessed at weeks 13 and 25 after allocation to evaluate their recovery and function using various outcome measures.

2 visits (in-person) at weeks 13 and 25 post allocation

Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus N, Denmark, 8200

Actively Recruiting

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Research Team

A

Andreas Bentzen, MHSc

I

Inger Mechlenburg, DMSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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