Clinical trial NCT06434272: Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Official title: The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Achilles Tendon Rupture
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Aalborg University Hospital
name: Gødstrup Hospital
name: Regionshospitalet Horsens
First posted: 2024-05-30
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This is an assessor-blinded, randomized, controlled multicenter trial with patients allocated 1:1 to one of two parallel groups, with follow-up times at weeks 13 and 25 after allocation.

Patients with an acute Achilles tendon rupture treated non-surgically are eligible for inclusion. All patients will receive a 12-week BFRE program, either in weeks 1-12 or 13-24 post allocation, as an add-on to usual care.

The BFRE program is performed three times weekly on the injured leg at 80% of the limb occlusion pressure required to restrict the arterial blood flow fully.

Outcome measures are assessed at baseline, week 13, and week 25 after allocation. The primary outcome at the week 13 follow-up is the Single-Leg Heel-Raise test which assesses the patient's ability to raise the heel of the injured leg a minimum of 2 cm. The primary outcome at the week 25 follow-up is the Achilles Total Tendon Rupture Score which assesses the patient's self-reported symptoms and physical activity.

During most of the initial trial phase (weeks 1-12), patients are treated at local hospitals, where recruitment, assessment, and randomization occur. Usual care at the hospitals consists of ankle immobilization with a gradual return to weight-bearing in the following weeks. In the latter half of the trial phase (weeks 13-24), patients have transitioned to municipal care, where usual care includes diverse exercises performed at home or training facilities.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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
* other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.)

Primary outcomes:
measure: Single-leg heel-rise test
timeFrame: Primary outcome at 13 week test. Measured as a secondary outcome at 25 week test.
measure: Achilles tendon Total Rupture Score (ATRS)
timeFrame: 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:
measure: 30 seconds unilateral Sit to Stand test
timeFrame: The test will be performed on both legs at 13 week test and 25 test.
measure: Calf circumference
timeFrame: The measurement will be performed on both legs at 13 week test and 25 test.
measure: Thigh circumference
timeFrame: The measurement will be performed on both legs at 13 week test and 25 test.
measure: Achilles tendon elongation (ATRA)
timeFrame: The test will be performed on both legs at 13 week test and 25 test.
measure: Single-leg heel-rise height
timeFrame: The test will be performed on both legs at 13 week test and 25 week test.
measure: Single-leg heel-rise endurance test
timeFrame: The test will be performed on both legs at 25 week test.
measure: Tampa Scale of Kinesiophobia 13-items (TSK-13)
timeFrame: TSK-13 is measured at baseline, 13 week test, and 25 test.
measure: International Physical Activity Questionnaire-short form (IPAQ-SF)
timeFrame: IPAQ-SF is measured at baseline through recall of pre-injury condition, 13 week test, and 25 week test.
measure: Adverse events
timeFrame: Measured continously, and evaluated at 13 week test and 25 week test.
Other outcomes:
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Measured at 25 week test.
measure: Global rating of change
timeFrame: Measured at 13 week test and 25 week test.
measure: Exercise adherence and progression
timeFrame: Measured continously, and evaluated at 13 week test and 25 week test.
measure: 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
timeFrame: Measured at baseline.
measure: Limb Occlusion Pressure
timeFrame: Measured at baseline for the Early BFRE-group, and measured at 13 week test for the Late BFRE-group.
measure: Drop-out rate
timeFrame: Recorded throughout the study-period, and will be evaluated at 13 week test and 25 week test.
measure: Concomitant exercise performed as part of usual care
timeFrame: Measured continuously and evaluated at the 25 week test.
measure: EuroQol-5 Dimension-5 Levels (EQ-5D-5L)
timeFrame: EQ-5D-5L is measured at baseline, capturing both the recalled pre-injury condition and the current condition, as well as at the 13-week and 25-week tests.
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Andreas Bentzen, MHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Inger Mechlenburg, DMSc
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital
name: Per H. Gundtoft, MD, PhD
role: STUDY_DIRECTOR
affiliation: Regionshospitalet Horsens
name: Stian L. Jørgensen, PT, PhD
role: STUDY_DIRECTOR
References: