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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

HIV+active group will perform exercise training, while HIV+inactive and HIV- groups will not undergo intervention.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Active HIV-infected patients

Exercise training

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

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

Inactive HIV-infected patients

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy subjects

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes