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

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ClinicalTrials.gov Identifier: NCT03343522
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Rio de Janeiro State University
Information provided by (Responsible Party):
Juliana Pereira Borges, Instituto Nacional de Cardiologia de Laranjeiras

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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Exercise Training in Vascular Function of Patients Living With HIV
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Sedentarism
Patients assigned to this arm shall not perform regular exercise training.
Experimental: Exercise Training
Patients assigned to this arm will be enrolled in exercise training program.
Behavioral: Exercise
A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343522


Contacts
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Contact: Juliana P Borges, PhD 55 21 992348072 julipborges@gmail.com
Contact: Gabriella O Lopes 55 21 979576950 gabriella.olopes@hotmail.com

Locations
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Brazil
Rio de Janeiro State University Recruiting
Rio De Janeiro, RJ, Brazil, 20550-900
Contact: Juliana P Borges, PhD    55 21 25620775    julipborges@gmail.com   
Contact: Gabriella O Lopes    55 21 979576950    gabriella.olopes@hotmail.com   
Sponsors and Collaborators
Instituto Nacional de Cardiologia de Laranjeiras
Rio de Janeiro State University
Investigators
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Principal Investigator: Juliana P Borges, PhD Insituto Nacional de Cardiologia and Rio de Janeiro State University

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Responsible Party: Juliana Pereira Borges, Principal Investigator, Instituto Nacional de Cardiologia de Laranjeiras
ClinicalTrials.gov Identifier: NCT03343522     History of Changes
Other Study ID Numbers: CAAE42162815.5.0000.5272
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juliana Pereira Borges, Instituto Nacional de Cardiologia de Laranjeiras:
Vascular function
Physical training
Laser Speckle Contrast Imaging