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

NCT ID: NCT03392805

Last Updated: 2018-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

HIV-1-infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sedentary life style

Group Type: EXPERIMENTAL

physical activity

Intervention Type: BEHAVIORAL

beginning of regular physical activity under the supervision of a coach

physically active life style

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

physical activity

beginning of regular physical activity under the supervision of a coach

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Giancarlo Ceccarelli

Reasercher co-PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gabriella d'Ettorre, MD PhD

Role: CONTACT

gabriella.dettorre@uniroma1.it

+39-06-49970324

Giancarlo Ceccarelli, MD PhD MSc

Role: CONTACT

giancarlo.ceccarelli@uniroma1.it

+39-06-49970900

Facility Contacts

Gabriella d'Ettorre, MD PhD

Role: primary

gabriella.dettorre@uniroma1.it

+39-06-49970324

Giancarlo Ceccarelli, MD PhD MSc

Role: backup

gabriella.dettorre@uniroma1.it

+39-06-49970900

Other Identifiers

DPHID-UniRoma04

Identifier Type: -

Identifier Source: org_study_id