The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Single-leg heel-rise test
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years or older
- •have started initial treatment within 72 hours of Achilles tendon rupture
- •understand written and spoken Danish
排除标准
- •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.
- •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.)
研究组 & 干预措施
Early initiated Blood Flow Restriction Exercise
Receives an intervention in adjunct to usual care in weeks 1-12, and continues with usual care in weeks 13-24.
干预措施: Early exercise with partial Blood Flow Restriction (Other)
Late initiated Blood Flow Restriction Exercise
Receives usual care in weeks 1-12, and receives an intervention in adjunct to usual care weeks 13-24.
干预措施: Late exercise with partial Blood Flow Restriction (Other)
结局指标
主要结局
Single-leg heel-rise test
时间窗: 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)
时间窗: 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).
次要结局
- 30 seconds unilateral Sit to Stand test(The test will be performed on both legs at 13 week test and 25 test.)
- Calf circumference(The measurement will be performed on both legs at 13 week test and 25 test.)
- Thigh circumference(The measurement will be performed on both legs at 13 week test and 25 test.)
- Achilles tendon elongation (ATRA)(The test will be performed on both legs at 13 week test and 25 test.)
- Single-leg heel-rise height(The test will be performed on both legs at 13 week test and 25 week test.)
- Single-leg heel-rise endurance test(The test will be performed on both legs at 25 week test.)
- Tampa Scale of Kinesiophobia 13-items (TSK-13)(TSK-13 is measured at baseline, 13 week test, and 25 test.)
- 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.)
- Adverse events(Measured continously, and evaluated at 13 week test and 25 week test.)