- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04512456
Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training
March 6, 2023 updated by: Juliana Pereira Borges, Instituto Nacional de Cardiologia de Laranjeiras
Autonomic and Hemodynamic Responses to Muscular Ergoreflex Activation in People Living With HIV/AIDS: Effects of Exercise Training.
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
63
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active HIV-infected patients
Exercise training
|
Exercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises.
|
No Intervention: Inactive HIV-infected patients
No intervention.
|
|
No Intervention: Healthy subjects
No intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Blood Pressure at 3 months
Time Frame: Baseline and 3 months of follow-up
|
Blood pressure will be assessed by a digital sphygmomanometer.
|
Baseline and 3 months of follow-up
|
Change from Baseline Heart Rate Variability at 3 months
Time Frame: Baseline and 3 months of follow-up
|
Heart rate variability will be assessed by a heart rate monitor.
|
Baseline and 3 months of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Heart Rate at 3 months
Time Frame: Baseline and 3 months of follow-up
|
Heart rate will be evaluated beat-to-beat by means of a heart rate monitor.
|
Baseline and 3 months of follow-up
|
Change from Baseline Peripheral Vascular Resistance at 3 months
Time Frame: Baseline and 3 months of follow-up
|
Peripheral Vascular Resistance will be evaluated by photpletismography.
|
Baseline and 3 months of follow-up
|
Change from Baseline Stroke Volume at 3 months
Time Frame: Baseline and 3 months of follow-up
|
Stroke Volume will be evaluated by photoplethysmography.
|
Baseline and 3 months of follow-up
|
Change from Baseline Cardiac Output at 3 months
Time Frame: Baseline and 3 months of follow-up
|
Cardiac Output will be evaluated by photoplethysmography.
|
Baseline and 3 months of follow-up
|
Change from Baseline Blood Lactate at 3 months
Time Frame: Baseline and 3 months of follow-up.
|
Blood Lactate will be determined by the YSL 2700 analyzer.
|
Baseline and 3 months of follow-up.
|
Change from Baseline Anthropometric markers at 3 months
Time Frame: Baseline and 3 months of follow-up.
|
Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer.
|
Baseline and 3 months of follow-up.
|
Change from Baseline handgrip maximal voluntary contraction at 3 months
Time Frame: Baseline and 3 months of follow-up.
|
Handgrip maximal voluntary contraction will be assessed using a hydraulic handgrip dynamometer.
|
Baseline and 3 months of follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2024
Primary Completion (Anticipated)
December 31, 2025
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
August 7, 2020
First Submitted That Met QC Criteria
August 12, 2020
First Posted (Actual)
August 13, 2020
Study Record Updates
Last Update Posted (Estimate)
March 7, 2023
Last Update Submitted That Met QC Criteria
March 6, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAPERJ E-26/010.100935/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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