Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection (PRIMO)
研究概览
详细说明
Many studies document that exercise and physical activity can have an anti-inflammatory effect, while there is evidence that a sedentary lifestyle could be the basis for the development of systemic inflammation and increased cardiovascular risk. This occurs because a sedentary lifestyle leads to the accumulation of visceral fat, and this is accompanied by an increase in adipokine release and infiltration of adipose tissue by the pro-inflammatory immune cells. Furthermore, the imbalance between immune processes and metabolic processes is associated with the development of insulin resistance, atherosclerosis and neurodegeneration.
The primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.
To evaluate this hypothesis, the following parameters will be analyzed: evaluation of immune-activation levels, of metabolic parameters, of cardiac function, of immuno-virological set-up, of dietary intake and of physical performance indices in HIV-positive patients with a sedentary lifestyle; these data will be compared with the values measured in the same HIV positive population with a sedentary lifestyle after three months of regular physical activity.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Rome、意大利、00161
- 招聘中
- Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"
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接触：
- Gabriella d'Ettorre, MD PhD
- 电话号码：+39-06-49970324
- 邮箱：gabriella.dettorre@uniroma1.it
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接触：
- Giancarlo Ceccarelli, MD PhD MSc
- 电话号码：+39-06-49970900
- 邮箱：gabriella.dettorre@uniroma1.it
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首席研究员：
- Giancarlo Ceccarelli, MD PhD MSc
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首席研究员：
- Gabriella d'Ettorre, MD PhD
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首席研究员：
- Vincenzo Vullo, MD
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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:
- Patients aged 18-60 years
- Patients who have signed informed consent
- HIV positive patients
- Patients who have performed a sports medical examination with ECG and are suitable for non-competitive physical activity.
Exclusion Criteria:
- Anemia, pregnancy or any other contraindication to blood sampling and sports activity
- Patients suffering from cardiomyopathies and ischemic heart disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：sedentary life style
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beginning of regular physical activity under the supervision of a coach
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无干预：physically active life style
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Delta between Rockport Walking Test value at T0 and T6
大体时间：6 months
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6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Delta between CD4+CD38+ value at T0 and T6
大体时间：6 months
|
6 months
|
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Delta between CD8+CD38+ value at T0 and T6
大体时间：6 months
|
6 months
|
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Delta between CD4+HLADR+ value at T0 and T6
大体时间：6 months
|
6 months
|
|
Delta between CD8+HLADR+ value at T0 and T6
大体时间：6 months
|
6 months
|
|
Delta between TNF-α value at T0 and T6
大体时间：6 months
|
6 months
|
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Delta between IL-6 value at T0 and T6
大体时间：6 months
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6 months
|
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Delta between adiponectin value at T0 and T6
大体时间：6 months
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6 months
|
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Delta between resistinat T0 and T6
大体时间：6 months
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6 months
|
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Delta between leptin value at T0 and T6
大体时间：6 months
|
6 months
|
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Delta between maximal Oxygen uptake value at T0 and T6
大体时间：6 months
|
6 months
|
合作者和调查者
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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