Clinical trial NCT04512456: 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
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Lead sponsor: Instituto Nacional de Cardiologia de Laranjeiras
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State University
First posted: 2020-08-13
Enrollment: 63
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HIV+active group will perform exercise training, while HIV+inactive and HIV- groups will not undergo intervention.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change from Baseline Blood Pressure at 3 months
timeFrame: Baseline and 3 months of follow-up
measure: Change from Baseline Heart Rate Variability at 3 months
timeFrame: Baseline and 3 months of follow-up
Secondary outcomes:
measure: Change from Baseline Heart Rate at 3 months
timeFrame: Baseline and 3 months of follow-up
measure: Change from Baseline Peripheral Vascular Resistance at 3 months
timeFrame: Baseline and 3 months of follow-up
measure: Change from Baseline Stroke Volume at 3 months
timeFrame: Baseline and 3 months of follow-up
measure: Change from Baseline Cardiac Output at 3 months
timeFrame: Baseline and 3 months of follow-up
measure: Change from Baseline Blood Lactate at 3 months
timeFrame: Baseline and 3 months of follow-up.
measure: Change from Baseline Anthropometric markers at 3 months
timeFrame: Baseline and 3 months of follow-up.
measure: Change from Baseline handgrip maximal voluntary contraction at 3 months
timeFrame: Baseline and 3 months of follow-up.
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Rio de Janeiro State University
state: RJ
Study officials:
affiliation: Rio de Janeiro State University
name: Julana P Borges, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.