Clinical trial NCT03343522: The Effects of Exercise Training in Vascular Function of Patients Living With HIV
Official title: The Effects of Exercise Training in Vascular Function of Patients Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Vascular function
Physical training
Laser Speckle Contrast Imaging
Lead sponsor: Instituto Nacional de Cardiologia de Laranjeiras
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State University
First posted: 2017-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear that the aerobic exercise training induces improvements in autonomic control and vascular function, through increases in vasodilator agents and blood vessels number. However, the investigators could not find previous works that studied the microvascular function in response to exercise training in HIV patients.

Objectives: To study the impact of aerobic exercise training in endothelial function of HIV patients. In addition, the investigators will verify the association of the physical fitness to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients.

Methods: The study subjects will be composed by HIV patients, that will be randomly divided in two different groups: exercised and sedentary. The subjects will be tested before and after training in regards to endothelial function, nitric oxide bioavailability, physical fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary exercise test, and biochemical tests; respectively. The exercise training will be performed in a treadmill for 12 weeks, 3 times a week, 40 minutes each section.

Expected Results: The investigators expect to achieve markers that will help in understanding the interaction of HIV with several factors that contribute to an increased endothelial function after exercise training.

Detailed description: HIV-infection triggers a massive oxygen reactive species production, increasing oxidative stress and vascular complications. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among HIV-infected patients (HIVP), exercise-related effects upon macro-and-microvascular endothelial function and oxidative stress in HIVP have not been previously reported.

Eligibility criteria: Inclusion Criteria:

* sedentarism for at least 6 months;
* diagnosis of HIV infection.

Exclusion Criteria:

* opportunistic diseases;
* nephropathies;
* cardiovascular diseases;
* locomotor limitations;
* liver diseases.

Primary outcomes:
measure: Skin microvascular blood flow
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Peak Oxygen consumption
timeFrame: Baseline and 3 months
measure: Nitrite/nitrate
timeFrame: Baseline and 3 months
measure: Body fat
timeFrame: Baseline and 3 months
measure: Forearm macrovascular blood flow
timeFrame: Baseline and 3 months
measure: Capillary density
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Rio de Janeiro State University
state: RJ
Study officials:
affiliation: Insituto Nacional de Cardiologia and Rio de Janeiro State University
name: Juliana P Borges, PhD
role: PRINCIPAL_INVESTIGATOR
References: