Randomized, Monocentric and Multidisciplinary Study of the Effects of an Intensive Rehabilitation by Interval Training With Active Recovery in Peripheral Arterial Disease With Claudication
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery
研究概览
简要总结
Rehabilitation is the first intention treatment of peripheral arterial disease (PAD) with claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to patients with PAD have recently been proved effective and defined in many guidelines. Supervised walking training on treadmill is recommended. Usually patients walk up to a mild or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then stop until pain completely subsides and walk again .
The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by alternating short sequences of intensive training and active recovery (without rest).
详细描述
Fractionated mode of training with active recovery has been proved effective in sport training as well as in Cardiac rehabilitation. We hypothesized it might be also interesting in the rehabilitation of patients with a peripheral arterial disease. The active recovery period might magnified the beneficial effect of a short intensive training.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient (male/female) between 18 and 80 years
- •Patient with Fontaine stage II PAD confirmed by clinic, duplex ultrasound and ankle-to-brachial systolic blood pressure index
- •Cardiac status compatible with an intensive gait rehabilitation (checked by a consultation with a cardiologist, including interview, clinical examination, electrocardiograph, and effort test on ergocycle).
- •Volunteer to take part in the study, having sign the consent form after receiving sufficient information and the information leaflet
- •Person affiliated to social security or the recipient of a similar scheme
- •Not Inclusion Criteria:
- •Exercise tolerance limited by other factors than claudication (eg, coronary artery disease, dyspnea, poorly controlled blood pressure
- •walking limited by other pathology
- •osteoarticular lower limbs pathology
- •abdominal aortic aneurysm > 4 cm
- •pseudo-flu-like feverish syndromes in evolution (myocarditis or pericarditis)
- •Person deprived of liberty by a legal or administrative decision, person under legal protection
- •Person currently participating in a clinical trial or having taken part in a clinical trial in the month preceding inclusion
- •Patient presenting with a history of mental or psychiatric illness or any other factor restricting his/her ability to participate in an informed manner and in compliance with the protocol
排除标准
- •Impossibility to perform protocol whatever reason
结局指标
主要结局
Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery
时间窗: Between day 0 and day 28
Change in walking distance between day 0 and day 28, measured on a graded treadmill test
次要结局
- One year follow-up(one year)
- Reproducibility test of the walking graduated treadmill(Day 0 et day 1)
- Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.(Between day 0 and day 28)