Exercise Training Under Hypoxic Conditions in Lower Extremity Artery Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Flow-mediated dilation
研究概览
简要总结
The aim of this randomized controlled trial is to:
Phase I: To explore, in a first pilot phase, the adequate combination of hypoxia severity and exercise intensity in patients with symptomatic lower extremity artery disease (LEAD). Acute walking performances and physiological responses (vascular and muscular) to a normobaric hypoxic exercise performed will be assessed at two different altitudes (1500 m and 2500 m).
详细描述
The results of this first phase will then be used to determine the optimal hypoxic level for the exercise training program which will be assessed during the Phase II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Patients with symptomatic LEAD (Fontaine stage ≥ IIa)
- •ABI ≤ 0.9
- •TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency)
- •Signed written informed consent form
排除标准
- •Neurological and neuromuscular disorders which can limit balance and walking
- •Any history of altitude-related sickness
- •Any health risks (assessed during clinical history) linked to hypoxia exposure
- •Acclimatization or exposure to hypoxia of more than 2000 m for more than 48 h during a period of 6 months before the study
- •Medication required for the treatment of migraines, claustrophobia that may interfere with the interpretation of the results
- •Obstructive sleep apnea (> 25 Apnea-Hypopnea Index)
- •Prior leg/foot amputation
- •Pregnant women
- •Cardiac contraindication to exercise
结局指标
主要结局
Flow-mediated dilation
时间窗: Before and after each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
Flow-mediated dilation before and after the 6 min treadmill test
Pulse oxygen saturation
时间窗: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
Pulse oxygen saturation during the 6 min treadmill test
Walking performance
时间窗: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
Total walking distance (in meters) during the 6 min treadmill test
Pain free walking time
时间窗: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
Pain free walking time during the 6 min treadmill test
Muscle oxygenation during exercise
时间窗: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
Muscle oxygenation during the 6 min treadmill test (assessed by near-infrared spectroscopy)
Pulse wave velocity
时间窗: Before and after each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
Pulse wave velocity before and after the 6 min treadmill test
次要结局
- Ankle-brachial index(Before and after each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week))
- Rate of perceived exertion(After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week))
- Leg pain(After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week))
- Toe-brachial index(Before and after each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week))
研究者
Lucia Mazzolai
Principal Investigator
Centre Hospitalier Universitaire Vaudois