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临床试验/NCT03392805
NCT03392805Unknown不适用

Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: physical activity (Behavioral)

physically active life style

No Intervention

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

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giancarlo Ceccarelli

Reasercher co-PI

University of Roma La Sapienza

研究点 (2)

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