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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343522
• Other study ID #: CAAE42162815.5.0000.5272
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: March 3, 2023

Study information

• Verified date: March 2023
• Source: Instituto Nacional de Cardiologia de Laranjeiras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 3, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• sedentarism for at least 6 months;

• diagnosis of HIV infection.

Exclusion Criteria:

• opportunistic diseases;

• nephropathies;

• cardiovascular diseases;

• locomotor limitations;

• liver diseases.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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).

Locations

Country	Name	City	State
Brazil	Rio de Janeiro State University	Rio De Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia de Laranjeiras	Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin microvascular blood flow	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.	Baseline and 3 months
Secondary	Peak Oxygen consumption	Measured at a maximal graded exercise test.	Baseline and 3 months
Secondary	Nitrite/nitrate	Colorimetric assay kit	Baseline and 3 months
Secondary	Body fat	Dual-energy X-ray absorptiometry.	Baseline and 3 months
Secondary	Forearm macrovascular blood flow	Forearm macrovascular blood flow will be evaluated by venous occlusion plethysmography.	Baseline and 3 months
Secondary	Capillary density	Capillary density will be evaluated by high-resolution intra-vital color microscopy.	Baseline and 3 months