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

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.

Study Overview

• Status: Unknown
• Conditions: HIV-1-infection
• Intervention / Treatment: Behavioral: physical activity

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Recruiting
    • Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"
    • Contact: Gabriella d'Ettorre, MD PhD; Phone Number: +39-06-49970324; Email: gabriella.dettorre@uniroma1.it
    • Contact: Giancarlo Ceccarelli, MD PhD MSc; Phone Number: +39-06-49970900; Email: gabriella.dettorre@uniroma1.it
    • Principal Investigator: Giancarlo Ceccarelli, MD PhD MSc
    • Principal Investigator: Gabriella d'Ettorre, MD PhD
    • Principal Investigator: Vincenzo Vullo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sedentary life style	Behavioral: physical activity; beginning of regular physical activity under the supervision of a coach
No Intervention: physically active life style

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Delta between Rockport Walking Test value at T0 and T6	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Delta between CD4+CD38+ value at T0 and T6	6 months
Delta between CD8+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 IL-6 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 leptin value at T0 and T6	6 months
Delta between maximal Oxygen uptake value at T0 and T6	6 months

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; HIV Infections; Infections; Communicable Diseases
• Other Study ID Numbers: DPHID-UniRoma04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No