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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
Instituto Nacional de Cardiologia de Laranjeiras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV Infections

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 7, 2020
    Last Updated
    March 6, 2023
    Sponsor
    Instituto Nacional de Cardiologia de Laranjeiras
    Collaborators
    Rio de Janeiro State University
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    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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