Achilles Tendon Rupture
Conditions
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.
Interventions
OTHEREarly exercise with partial Blood Flow Restriction
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.
OTHERLate exercise with partial Blood Flow Restriction
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.
Sponsors
University of Aarhus
Aarhus University Hospital
Aalborg University Hospital
Gødstrup Hospital
Regionshospitalet Horsens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single-leg heel-rise test | Primary outcome at 13 week test. Measured as a secondary outcome at 25 week 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. |
| Achilles tendon Total Rupture Score (ATRS) | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 seconds unilateral Sit to Stand test | The test will be performed on both legs at 13 week test and 25 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 |
| Calf circumference | The measurement will be performed on both legs at 13 week test and 25 test. | 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. |
| Thigh circumference | The measurement will be performed on both legs at 13 week test and 25 test. | 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. |
| Achilles tendon elongation (ATRA) | The test will be performed on both legs at 13 week test and 25 test. | 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. |
| Single-leg heel-rise height | The test will be performed on both legs at 13 week test and 25 week test. | Patient's maximum heel-rise height measured in cm. 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. |
| Single-leg heel-rise endurance test | The test will be performed on both legs at 25 week test. | The maximal number of correct single-leg heel-rise repetitions is measured. 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 the wall. |
| Tampa Scale of Kinesiophobia 13-items (TSK-13) | TSK-13 is measured at baseline, 13 week test, and 25 test. | The TSK-13 is a 13-item self-reported measure for fear of movement or reinjury, that has previously been used in patients with Achilles tendon rupture. |
| International Physical Activity Questionnaire-short form (IPAQ-SF) | IPAQ-SF is measured at baseline through recall of pre-injury condition, 13 week test, and 25 week test. | The IPAQ-SF consists of 7 items on physical activity as time spent performing vigorous and moder-ate activities, the time spent walking, and time spent sitting during the past week. The IPAQ pro-vides an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting. |
| Adverse events | Measured continously, and evaluated at 13 week test and 25 week test. | The number of adverse events and serious adverse events will be recorded and reported to a Data Safety Monitoring Board. Adverse events are defined as unexpected medical events related to the initial treatment. Serious adverse event are complications requiring further inpatient care, such as re-rupture of the Achilles tendon, non-union of the Achilles tendon, or deep venous thromboembolism and pulmonary embolism. Muscle soreness or mild pain following exercise is expected and not con-sidered an adverse event. |
Countries
Denmark
Contacts
CONTACTAndreas Bentzen, MHSc
CONTACTInger Mechlenburg, DMSc
PRINCIPAL_INVESTIGATORAndreas Bentzen, MHSc
University of Aarhus
STUDY_DIRECTORInger Mechlenburg, DMSc
University of Aarhus
STUDY_DIRECTORPer H. Gundtoft, MD, PhD
Aarhus University Hospital
STUDY_DIRECTORStian L. Jørgensen, PT, PhD
Regionshospitalet Horsens
Outcome results
None listed