Effects of Combined Aerobic and Resistance Training in Patients With Intermittent Claudication
Effects of Home-based Combined Aerobic and Resistance Training on Walking Capacity, Circulating Endothelial Progenitor Cells AND Endothelial Function in Patients With Intermittent Claudication
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.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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PG
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Perugia、PG、意大利、06132
- Ospedale "Santa Maria della Misericordia" di Perugia
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Healthy control
Voluntary subjects without peripheral arterial disease
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假比较器：IC patients, no exercise
Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, given advices to perform regular aerobic activity
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general recommendation to perform regular aerobic physical activity
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有源比较器：IC patients, exercise
Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, home-based combined physical exercise
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Five training sessions weekly for 12 weeks are scheduled.
Each session lasts 60 minutes divided into 45 minutes of aerobic workout and 15 minutes of circuit training.
The aerobic workout consists of walking on a flat floor or on a slight uphill (maximum slope 3%): patients should walk until submaximal walking capacity (80% of their MWT) and rest as they would experience pain at the lower limbs; afterwards, they should start to walk again, once the pain was improved.
Resistance training consists of calisthenics exercises focused on trunk and lower limbs muscles (bicycle, flutter kicks, squats, lunges, calf raises, wall sits and power press) with at least 3 repetitions for each exercise, interspersed by 30 seconds recovery.
Duration of repetitions increases every 3 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Endothelial Microparticles (EMPs)
大体时间：week 0 - week 12
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hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry
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week 0 - week 12
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Endothelial Progenitor Cells (EPCs)
大体时间：week 0 - week 12
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hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry
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week 0 - week 12
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Maximum Walking Time
大体时间：week 0 - week 12
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functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test
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week 0 - week 12
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Pain-free Walking Time
大体时间：week 0 - week 12
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maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test
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week 0 - week 12
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Flow-mediated Dilation
大体时间：week 0 - week 12
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ultrasonographic evaluation of endothelial function
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week 0 - week 12
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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