Effects of Home-based Combined Aerobic and Resistance Training on Walking Capacity, Circulating Endothelial Progenitor Cells AND Endothelial Function in Patients With Intermittent Claudication
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Endothelial Microparticles (EMPs)
研究概览
简要总结
Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium.
The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program.
The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •history of stable intermittent claudication (PAD, stage II Fontaine)
- •resting ankle-brachial index (ABI) <0,9 and the presence of occlusion or significant stenosis at the color-Doppler duplex ultrasound scanning
排除标准
- •lower-limb ischemic rest pain or gangrene (Fontaine stages III and IV)
- •inability to obtain the ABI value or to perform a walking test
- •exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity)
- •end-stage liver or renal failure
- •acute or chronic inflammatory conditions
- •history of recent (<6 months) acute coronary syndrome, cerebrovascular event or inducible myocardial ischemia
- •treatment with drugs known to affect walking capacity, including calcium-channel blockers, β-blockers and angiotensin-converting enzyme inhibitors.
结局指标
主要结局
Endothelial Microparticles (EMPs)
时间窗: week 0 - week 12
hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry
Endothelial Progenitor Cells (EPCs)
时间窗: week 0 - week 12
hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry
Maximum Walking Time
时间窗: week 0 - week 12
functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test
Pain-free Walking Time
时间窗: week 0 - week 12
maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test
Flow-mediated Dilation
时间窗: week 0 - week 12
ultrasonographic evaluation of endothelial function
次要结局
未报告次要终点
研究者
Rita Lombardini
Principal Investigator
University Of Perugia