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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
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.
A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).
- 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.
- Peak Oxygen consumption [ Time Frame: Baseline and 3 months ]Measured at a maximal graded exercise test.
- Nitrite/nitrate [ Time Frame: Baseline and 3 months ]Colorimetric assay kit
- Body fat [ Time Frame: Baseline and 3 months ]Dual-energy X-ray absorptiometry.
- Forearm macrovascular blood flow [ Time Frame: Baseline and 3 months ]Forearm macrovascular blood flow will be evaluated by venous occlusion plethysmography.
- Capillary density [ Time Frame: Baseline and 3 months ]Capillary density will be evaluated by high-resolution intra-vital color microscopy.
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
|Contact: Juliana P Borges, PhD||55 21 firstname.lastname@example.org|
|Contact: Gabriella O Lopes||55 21 email@example.com|
|Rio de Janeiro State University||Recruiting|
|Rio De Janeiro, RJ, Brazil, 20550-900|
|Contact: Juliana P Borges, PhD 55 21 25620775 firstname.lastname@example.org|
|Contact: Gabriella O Lopes 55 21 979576950 email@example.com|
|Principal Investigator:||Juliana P Borges, PhD||Insituto Nacional de Cardiologia and Rio de Janeiro State University|