Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture

ConditionAchilles Tendon Rupture

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Aarhus

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

aged 18 years or older

have started initial treatment within 72 hours of Achilles tendon rupture

understand written and spoken Danish

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Early exercise with partial Blood Flow Restriction
Other intervention
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.
Late exercise with partial Blood Flow Restriction
Other intervention
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.

Treatment groups

218 Participants

are divided into 2 treatment groups

Group A: Early initiated Blood Flow Restriction ExerciseExperimental treatment 1 intervention

Group B: Late initiated Blood Flow Restriction ExerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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).

Time frame

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

30 seconds unilateral Sit to Stand test

The unilateral 30 second Sit to Stand test (unilateral 30STS) is a clinical test of lower extremity function. The unilateral 30STS tests how many correct repetitions of a sit to stand from a chair, a patient can complete in 30 seconds

Time frame

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

Calf circumference

The calf circumference is measured in centimeters (cm) on both legs using a tape measure 15 cm below the medial palpable joint line of the knee. Repeated measurements will be made until a consistent measurement is found.

Time frame

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

Thigh circumference

Thigh circumference is measured in centimeters (cm) on both legs using a tape measure 10 cm proximal to the apex patella. During measurement patients lay supine on an examination table with knees bent in a 90-degree angle.

Time frame

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

Achilles tendon elongation (ATRA)

The Achilles tendon length is indirectly measured by the Achilles tendon resting angle (ATRA), measuring the difference in passive dorsiflexion when lying prone with knees in a 90-degree angle.

Time frame

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

Other outcomes

Patient Acceptable Symptom State (PASS)

Patients are asked on a questionnaire whether they think their current symptom state is satisfactory (yes/no).

Time frame

Measured at 25 week test.

Global rating of change

Perceived effect of intervention is rated on a 7-point likert scale from significantly worse to significantly better.

Time frame

Measured at 13 week test and 25 week test.

Exercise adherence and progression

Patients' adherence with the exercise sessions (completed sessions) and progression during the intervention period will be recorded in self-reported exercise diaries by the patients. Exercise diaries will also be provided to patients in the control group, to monitor usual care exercise.

Time frame

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

Demographic data consisting of sex, age, weight, height, BMI, marital status, employment status, alcohol intake, nicotine intake, injury mechanism, and pre-injury ankle pain condition

Descriptive demographic data.

Time frame

Measured at baseline.

Sponsors and contacts

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University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Aalborg University Hospital

Collaborator

Gødstrup Hospital

Collaborator

Regionshospitalet Horsens

Collaborator

Source ClinicalTrials.gov

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