The Effects of Exercise Training in Vascular Function of Patients Living With HIV
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for HIV/AIDS focused on measuring Vascular function, Physical training, Laser Speckle Contrast Imaging
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.
Sites / Locations
- Rio de Janeiro State University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Sedentarism
Exercise Training
Arm Description
Patients assigned to this arm shall not perform regular exercise training.
Patients assigned to this arm will be enrolled in exercise training program.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Peak Oxygen consumption
Measured at a maximal graded exercise test.
Nitrite/nitrate
Colorimetric assay kit
Body fat
Dual-energy X-ray absorptiometry.
Forearm macrovascular blood flow
Forearm macrovascular blood flow will be evaluated by venous occlusion plethysmography.
Capillary density
Capillary density will be evaluated by high-resolution intra-vital color microscopy.
Full Information
NCT ID
NCT03343522
First Posted
November 10, 2017
Last Updated
March 6, 2023
Sponsor
Instituto Nacional de Cardiologia de Laranjeiras
Collaborators
Rio de Janeiro State University
1. Study Identification
Unique Protocol Identification Number
NCT03343522
Brief Title
The Effects of Exercise Training in Vascular Function of Patients Living With HIV
Official Title
The Effects of Exercise Training in Vascular Function of Patients Living With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
March 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia de Laranjeiras
Collaborators
Rio de Janeiro State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Vascular function, Physical training, Laser Speckle Contrast Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sedentarism
Arm Type
No Intervention
Arm Description
Patients assigned to this arm shall not perform regular exercise training.
Arm Title
Exercise Training
Arm Type
Experimental
Arm Description
Patients assigned to this arm will be enrolled in exercise training program.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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 Measure Information:
Title
Skin microvascular blood flow
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Peak Oxygen consumption
Description
Measured at a maximal graded exercise test.
Time Frame
Baseline and 3 months
Title
Nitrite/nitrate
Description
Colorimetric assay kit
Time Frame
Baseline and 3 months
Title
Body fat
Description
Dual-energy X-ray absorptiometry.
Time Frame
Baseline and 3 months
Title
Forearm macrovascular blood flow
Description
Forearm macrovascular blood flow will be evaluated by venous occlusion plethysmography.
Time Frame
Baseline and 3 months
Title
Capillary density
Description
Capillary density will be evaluated by high-resolution intra-vital color microscopy.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana P Borges, PhD
Organizational Affiliation
Insituto Nacional de Cardiologia and Rio de Janeiro State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rio de Janeiro State University
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
20550-900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Exercise Training in Vascular Function of Patients Living With HIV
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