Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Delta between Rockport Walking Test value at T0 and T6
研究概览
简要总结
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. The primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Anemia, pregnancy or any other contraindication to blood sampling and sports activity
- •Patients suffering from cardiomyopathies and ischemic heart disease
研究组 & 干预措施
sedentary life style
干预措施: physical activity (Behavioral)
physically active life style
结局指标
主要结局
Delta between Rockport Walking Test value at T0 and T6
时间窗: 6 months
次要结局
- Delta between CD4+CD38+ value at T0 and T6(6 months)
- Delta between CD4+HLADR+ value at T0 and T6(6 months)
- Delta between CD8+HLADR+ value at T0 and T6(6 months)
- Delta between TNF-α value at T0 and T6(6 months)
- Delta between maximal Oxygen uptake value at T0 and T6(6 months)
- Delta between CD8+CD38+ value at T0 and T6(6 months)
- Delta between adiponectin value at T0 and T6(6 months)
- Delta between resistinat T0 and T6(6 months)
- Delta between IL-6 value at T0 and T6(6 months)
- Delta between leptin value at T0 and T6(6 months)
研究者
Giancarlo Ceccarelli
Reasercher co-PI
University of Roma La Sapienza
