Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое Early 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.
• Другое Late 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 usua

Первичные конечные точки

• Single-leg heel-rise test [Срок оценки: Primary outcome at 13 week test. Measured as a secondary outcome at 25 week test.]
• Achilles tendon Total Rupture Score (ATRS) [Срок оценки: 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.]

Вторичные конечные точки (9)

• 30 seconds unilateral Sit to Stand test [Срок оценки: The test will be performed on both legs at 13 week test and 25 test.]
• Calf circumference [Срок оценки: The measurement will be performed on both legs at 13 week test and 25 test.]
• Thigh circumference [Срок оценки: The measurement will be performed on both legs at 13 week test and 25 test.]
• Achilles tendon elongation (ATRA) [Срок оценки: The test will be performed on both legs at 13 week test and 25 test.]
• Single-leg heel-rise height [Срок оценки: The test will be performed on both legs at 13 week test and 25 week test.]
• Single-leg heel-rise endurance test [Срок оценки: The test will be performed on both legs at 25 week test.]
• Tampa Scale of Kinesiophobia 13-items (TSK-13) [Срок оценки: TSK-13 is measured at baseline, 13 week test, and 25 test.]
• International Physical Activity Questionnaire-short form (IPAQ-SF) [Срок оценки: IPAQ-SF is measured at baseline through recall of pre-injury condition, 13 week test, and 25 week test.]
• Adverse events [Срок оценки: Measured continously, and evaluated at 13 week test and 25 week test.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Aarhus University Hospital — Aarhus N

Идентификаторы

NCT: NCT06434272 · BEAN (1-10-72-192-23)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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