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

University of Roma La Sapienza

Status: Unknown

Conditions: HIV-1-infection

Treatments: Behavioral: physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT03392805

DPHID-UniRoma04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

sedentary life style

Experimental group

Treatment:

Behavioral: physical activity

physically active life style

No Intervention group