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

NCT ID: NCT03343522

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-10
• Study Completion Date: 2023-03-03

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sedentarism

Patients assigned to this arm shall not perform regular exercise training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise Training

Patients assigned to this arm will be enrolled in exercise training program.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: collaborator

Instituto Nacional de Cardiologia de Laranjeiras

OTHER

Sponsor Role: lead

Responsible Party

Juliana Pereira Borges

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliana P Borges, PhD

Role: PRINCIPAL_INVESTIGATOR

Insituto Nacional de Cardiologia and Rio de Janeiro State University

Locations

Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

CAAE42162815.5.0000.5272

Identifier Type: -

Identifier Source: org_study_id