Clinical trial NCT03392805: Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection
Official title: Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV-1-infection
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Delta between Rockport Walking Test value at T0 and T6
timeFrame: 6 months
Secondary outcomes:
measure: Delta between CD4+CD38+ value at T0 and T6
timeFrame: 6 months
measure: Delta between CD8+CD38+ value at T0 and T6
timeFrame: 6 months
measure: Delta between CD4+HLADR+ value at T0 and T6
timeFrame: 6 months
measure: Delta between CD8+HLADR+ value at T0 and T6
timeFrame: 6 months
measure: Delta between TNF-α value at T0 and T6
timeFrame: 6 months
measure: Delta between IL-6 value at T0 and T6
timeFrame: 6 months
measure: Delta between adiponectin value at T0 and T6
timeFrame: 6 months
measure: Delta between resistinat T0 and T6
timeFrame: 6 months
measure: Delta between leptin value at T0 and T6
timeFrame: 6 months
measure: Delta between maximal Oxygen uptake value at T0 and T6
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"
Study officials:
References: