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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03392805
Acronym
PRIMO
Enrollment
50
Registered
2018-01-08
Start date
2016-01-01
Completion date
2019-12-31
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

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.

Interventions

BEHAVIORALphysical activity

beginning of regular physical activity under the supervision of a coach

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Delta between Rockport Walking Test value at T0 and T66 months

Secondary

MeasureTime frame
Delta between CD8+CD38+ value at T0 and T66 months
Delta between CD4+HLADR+ value at T0 and T66 months
Delta between CD8+HLADR+ value at T0 and T66 months
Delta between TNF-α value at T0 and T66 months
Delta between CD4+CD38+ value at T0 and T66 months
Delta between adiponectin value at T0 and T66 months
Delta between resistinat T0 and T66 months
Delta between leptin value at T0 and T66 months
Delta between maximal Oxygen uptake value at T0 and T66 months
Delta between IL-6 value at T0 and T66 months

Countries

Italy

Contacts

Primary ContactGabriella d'Ettorre, MD PhD
gabriella.dettorre@uniroma1.it+39-06-49970324
Backup ContactGiancarlo Ceccarelli, MD PhD MSc
giancarlo.ceccarelli@uniroma1.it+39-06-49970900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026