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Recruiting NCT04512456

Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training

No phase Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise training.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: 30 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change from Baseline Blood Pressure at 3 months [Time frame: 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]
Secondary outcome measures (7)
  • Change from Baseline Heart Rate at 3 months [Time frame: 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]
  • Change from Baseline Stroke Volume at 3 months [Time frame: Baseline and 3 months of follow-up]
  • Change from Baseline Cardiac Output at 3 months [Time frame: Baseline and 3 months of follow-up]
  • Change from Baseline Blood Lactate at 3 months [Time frame: Baseline and 3 months of follow-up.]
  • Change from Baseline Anthropometric markers at 3 months [Time frame: 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Brazil · 1 center
  • Rio de Janeiro State University — Rio de Janeiro

Publications

  • 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. PMID 35303017

Identifiers

NCT: NCT04512456 · FAPERJ E-26/010.100935/2018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗