Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Assess efficacity of Adapted Physical Activity with localization of ischemia on maximum walking distance compared to Adapted Physical activity without localization of ischemia
研究概览
简要总结
The prevalence of peripheral arterial disease is 12.2% in France. Intermittent claudication is the most common symtom of this disease. During physical exercise, such as walking, blood oxygen (O2) requirements increase. The development of atherosclerosis in the lower limbs, causes narrowing of the arteries and limits the increase in blood flow required for muscular effort. Patients then experience muscle pain, the intensity of which gradually increases until it forces them to stop. After stopping, the pain subsides and disappears in less than 10 minutes.
The location of the pain (calves and/or thighs and/or buttocks) is related to the location of the ischemia (distal in the calf, proximal in the thigh or buttock, or proximo-distal if several locations). This can have different consequences on the biomechanical parameters of walking and muscle activity. To date, the impact of this localization on physical capacity has never been studied.
These limitations are very disabling and impact the quality of life of patients.
In addition, poor lower limb performance is associated with higher mortality. Reducing symptomatology and improving functional abilities is therefore a major issue in patients with peripheral arterial disease. This can be achieved through the practice of an Adapted Physical Activity, an essential recommendation in the care of patients with peripheral arterial disease.
Our main hypothesis is that the physical activity rehabilitation protocol "Activ'AO" will improve the functional capacities of patients with peripheral arterial disease who have followed the program with the localization of ischemia with a greater consideration than in patients in the group following a "standard" APA protocol. Improvements in functional abilities (such as walking) will lead to improvements in quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Lower Limb Peripheral Arterial Disease with IPSC < 0.90, arterial stenosis in the lower limbs and intermittent claudication
- •No contraindication to physical activity
- •Socially insured patients over 18 ;
- •Patient who has signed the consent form.
排除标准
- •Severe or unstable cardiopulmonary pathologies, contraindicating exercise training
- •Unstable angina or myocardial infarction <3 months
- •Severe rheumatological pathology of the lower limbs
- •Amputee of a lower or upper limb fitted with a device
- •Extensive dermatosis of the lower limbs
- •Known NYHA grade III or IV heart failure
- •Known severe respiratory pathology
- •Parkinson's disease, hemiplegia or paraplegia
- •Adults subject to enhanced protection, deprived of their liberty by judicial or administrative decision
- •Persons unable to consent
- •Be in a period of exclusion from other interventional research.
- •Any event (injury, surgery, etc.) occurring during the protocol period that could have an impact on results.
研究组 & 干预措施
APA with consideration of ischemia localization
干预措施: muscle strengthening targeted on ischemic areas (Other)
APA without consideration of ischemia localization
干预措施: global muscle strenghtening (Other)
结局指标
主要结局
Assess efficacity of Adapted Physical Activity with localization of ischemia on maximum walking distance compared to Adapted Physical activity without localization of ischemia
时间窗: 12 weeks after inclusion
The efficacity of Adapted Physical Activity was assessed by measure of maximum walking distance
次要结局
- Assess efficacity of Adapted Physical Activity with localization of ischemia on walking abilities compared to Adapted Physical activity without localization of ischemia(12 weeks after inclusion)
- Assess efficacity of Adapted Physical Activity with localization of ischemia on static balance compared to Adapted Physical activity without localization of ischemia(12 weeks after inclusion)
- Assess quality of Life(At week 12)
- Assess strength capacities(12 weeks after inclusion)
- Assess neuromuscular activity(12 weeks after inclusion)