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NCT Number: NCT04512456

Cardiovascular Responses to Exercise 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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rio de Janeiro State University

Rio de Janeiro, 20550-900, Brazil

Location status: Recruiting

Location contact

Juliana Borges

CONTACT

[email protected]

552123340775

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Training

Behavioral

Exercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Change from Baseline Stroke Volume at 3 months

    Time frame: Baseline and 3 months of follow-up

    Stroke Volume will be evaluated by photoplethysmography.

  4. Change from Baseline Cardiac Output at 3 months

    Time frame: Baseline and 3 months of follow-up

    Cardiac Output will be evaluated by photoplethysmography.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel S Gama

CONTACT

[email protected]

+552123340775

Juliana P Borges, Dr.

CONTACT

[email protected]

+552123340775

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia de Laranjeiras

Other

Collaborators

  • Rio de Janeiro State University

Registry information

Official study title

Autonomic and Hemodynamic Responses to Muscular Ergoreflex Activation in People Living With HIV/AIDS: Effects of Exercise Training.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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