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Completed

NCT Number: NCT03343522

The Effects of Exercise Training in Vascular Function of Patients Living With HIV

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exercise

Behavioral

A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).

Primary outcomes

  1. Skin microvascular blood flow

    Time frame: Baseline and 3 months

    Microvascular reactivity will be evaluated by laser speckle contrast imaging with laser wavelength of 785 nm in combination with iontophoresis of acetylcholine (ACh) and sodium nitroprusside (SNP) for noninvasive and continuous measurements of cutaneous microvascular flow changes in the forearm.

Secondary outcomes

  1. Peak Oxygen consumption

    Time frame: Baseline and 3 months

    Measured at a maximal graded exercise test.

  2. Nitrite/nitrate

    Time frame: Baseline and 3 months

    Colorimetric assay kit

  3. Body fat

    Time frame: Baseline and 3 months

    Dual-energy X-ray absorptiometry.

  4. Forearm macrovascular blood flow

    Time frame: Baseline and 3 months

    Forearm macrovascular blood flow will be evaluated by venous occlusion plethysmography.

  5. Capillary density

    Time frame: Baseline and 3 months

    Capillary density will be evaluated by high-resolution intra-vital color microscopy.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia de Laranjeiras

Other

Collaborators

  • Rio de Janeiro State University

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Nov 17, 2017
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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