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

HIV-1-infection Clinical Trial

— PRIMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392805
• Other study ID #: DPHID-UniRoma04
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2018
• Last updated: January 2, 2018
• Start date: January 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: University of Roma La Sapienza
• Contact: Gabriella d'Ettorre, MD PhD
• Phone: +39-06-49970324
• Email: gabriella.dettorre[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18-60 years

2. Patients who have signed informed consent

3. HIV positive patients

4. Patients who have performed a sports medical examination with ECG and are suitable for non-competitive physical activity.

Exclusion Criteria:

1. Anemia, pregnancy or any other contraindication to blood sampling and sports activity

2. Patients suffering from cardiomyopathies and ischemic heart disease

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• HIV-1-infection
• Infection

Intervention

Behavioral:
• physical activity
beginning of regular physical activity under the supervision of a coach

Locations

Country	Name	City	State
Italy	Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta between Rockport Walking Test value at T0 and T6		6 months
Secondary	Delta between CD4+CD38+ value at T0 and T6		6 months
Secondary	Delta between CD8+CD38+ value at T0 and T6		6 months
Secondary	Delta between CD4+HLADR+ value at T0 and T6		6 months
Secondary	Delta between CD8+HLADR+ value at T0 and T6		6 months
Secondary	Delta between TNF-a value at T0 and T6		6 months
Secondary	Delta between IL-6 value at T0 and T6		6 months
Secondary	Delta between adiponectin value at T0 and T6		6 months
Secondary	Delta between resistinat T0 and T6		6 months
Secondary	Delta between leptin value at T0 and T6		6 months
Secondary	Delta between maximal Oxygen uptake value at T0 and T6		6 months