Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training
Primary Purpose
HIV Infections
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional basic science trial for HIV Infections
Eligibility Criteria
Inclusion Criteria for people living with HIV:
- diagnosis of HIv infection for at least 5 years;
- use of combined antiretroviral therapy for at least 3 years;
- asymptomatic and free from opportunistic diseases at enrollment.
Exclusion Criteria:
- regular physical exercise;
- malnutrition;
- presence of coronary artery disease, ischemic diseases, pulmonary disease, diabetes, Chagas disease, tuberculosis, heart failure, hypertension;
- using pacemakers and/or antidepressant, antiarrhythmic or antihypertensive medication, especially beta-blockers.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Active HIV-infected patients
Inactive HIV-infected patients
Healthy subjects
Arm Description
Exercise training
No intervention.
No intervention.
Outcomes
Primary Outcome Measures
Change from Baseline Blood Pressure at 3 months
Blood pressure will be assessed by a digital sphygmomanometer.
Change from Baseline Heart Rate Variability at 3 months
Heart rate variability will be assessed by a heart rate monitor.
Secondary Outcome Measures
Change from Baseline Heart Rate at 3 months
Heart rate will be evaluated beat-to-beat by means of a heart rate monitor.
Change from Baseline Peripheral Vascular Resistance at 3 months
Peripheral Vascular Resistance will be evaluated by photpletismography.
Change from Baseline Stroke Volume at 3 months
Stroke Volume will be evaluated by photoplethysmography.
Change from Baseline Cardiac Output at 3 months
Cardiac Output will be evaluated by photoplethysmography.
Change from Baseline Blood Lactate at 3 months
Blood Lactate will be determined by the YSL 2700 analyzer.
Change from Baseline Anthropometric markers at 3 months
Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer.
Change from Baseline handgrip maximal voluntary contraction at 3 months
Handgrip maximal voluntary contraction will be assessed using a hydraulic handgrip dynamometer.
Full Information
NCT ID
NCT04512456
First Posted
August 7, 2020
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
NCT04512456
Brief Title
Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training
Official Title
Autonomic and Hemodynamic Responses to Muscular Ergoreflex Activation in People Living With HIV/AIDS: Effects of Exercise Training.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
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
Yes
5. Study Description
Brief Summary
Patients living with HIV (PLWHIV) have compromised muscle metaboreflex, which can cause exercise intolerance. This randomized controlled clinical trial will verify the effects of regular exercise on autonomic and hemodynamic responses to muscle ergoreflex activation in these patients. PLWHIV without regular physical exercise will be randomly assigned into an exercise training or a control group. The exercise training group will undergo regular physical exercise during 12 weeks (60-min session performed 3 times/wk with moderate intensity), while the control group will keep inactive. Another group consisted of inactive HIV-uninfected group will be included. The primary endpoints will be blood pressure and autonomic markers in response to the Stroop Color-Word Test and the activation of muscle ergoreflex, by means of the post-exercise circulatory arrest (PECA), which will be performed with and without the topical application of a capsaicin-based analgesic balm. Secondary endpoints will include heart rate, peripheral vascular resistance, stroke volume, cardiac output, blood lactate concentration, anthropometrics, and handgrip strength. The active and inactive PLWHIV groups will be evaluated before and after the exercise training, while the healthy group only at baseline.
Detailed Description
HIV-infection is associated to a reduced maximal cardiac output and blunted pressor reflex response to static handgrip exercise, which are suggestive of impaired ergoreflex activation. An abnormal ergoreflex activation may lead to exercise intolerance and increases in cardiovascular risk. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among patients living with HIV, exercise-related effects on ergoreflex sensitivity in these population have not been previously investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
HIV+active group will perform exercise training, while HIV+inactive and HIV- groups will not undergo intervention.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active HIV-infected patients
Arm Type
Experimental
Arm Description
Exercise training
Arm Title
Inactive HIV-infected patients
Arm Type
No Intervention
Arm Description
No intervention.
Arm Title
Healthy subjects
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Exercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises.
Primary Outcome Measure Information:
Title
Change from Baseline Blood Pressure at 3 months
Description
Blood pressure will be assessed by a digital sphygmomanometer.
Time Frame
Baseline and 3 months of follow-up
Title
Change from Baseline Heart Rate Variability at 3 months
Description
Heart rate variability will be assessed by a heart rate monitor.
Time Frame
Baseline and 3 months of follow-up
Secondary Outcome Measure Information:
Title
Change from Baseline Heart Rate at 3 months
Description
Heart rate will be evaluated beat-to-beat by means of a heart rate monitor.
Time Frame
Baseline and 3 months of follow-up
Title
Change from Baseline Peripheral Vascular Resistance at 3 months
Description
Peripheral Vascular Resistance will be evaluated by photpletismography.
Time Frame
Baseline and 3 months of follow-up
Title
Change from Baseline Stroke Volume at 3 months
Description
Stroke Volume will be evaluated by photoplethysmography.
Time Frame
Baseline and 3 months of follow-up
Title
Change from Baseline Cardiac Output at 3 months
Description
Cardiac Output will be evaluated by photoplethysmography.
Time Frame
Baseline and 3 months of follow-up
Title
Change from Baseline Blood Lactate at 3 months
Description
Blood Lactate will be determined by the YSL 2700 analyzer.
Time Frame
Baseline and 3 months of follow-up.
Title
Change from Baseline Anthropometric markers at 3 months
Description
Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer.
Time Frame
Baseline and 3 months of follow-up.
Title
Change from Baseline handgrip maximal voluntary contraction at 3 months
Description
Handgrip maximal voluntary contraction will be assessed using a hydraulic handgrip dynamometer.
Time Frame
Baseline and 3 months of follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for people living with HIV:
diagnosis of HIv infection for at least 5 years;
use of combined antiretroviral therapy for at least 3 years;
asymptomatic and free from opportunistic diseases at enrollment.
Exclusion Criteria:
regular physical exercise;
malnutrition;
presence of coronary artery disease, ischemic diseases, pulmonary disease, diabetes, Chagas disease, tuberculosis, heart failure, hypertension;
using pacemakers and/or antidepressant, antiarrhythmic or antihypertensive medication, especially beta-blockers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana P Borges, Dr.
Phone
+552123340775
Email
julipborges@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel S Gama
Phone
+552123340775
Email
profgabrielgama@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julana P Borges, Dr
Organizational Affiliation
Rio de Janeiro State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35303017
Citation
Gama G, Dos Santos Rangel MV, de Oliveira Coelho VC, Paz GA, de Matos CVB, Silva BP, Lopes GO, Lopes KG, Farinatti P, Borges JP. The effects of exercise training on autonomic and hemodynamic responses to muscle metaboreflex in people living with HIV/AIDS: A randomized clinical trial protocol. PLoS One. 2022 Mar 18;17(3):e0265516. doi: 10.1371/journal.pone.0265516. eCollection 2022.
Results Reference
derived
Learn more about this trial
Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training
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