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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorInstituto Nacional de Cardiologia de Laranjeiras

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise training

    Behavioral

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

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: Active HIV-infected patientsExperimental treatment 1 intervention
Group B: Inactive HIV-infected patientsNo intervention 0 interventions
Group C: Healthy subjectsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline Blood Pressure at 3 months

Blood pressure will be assessed by a digital sphygmomanometer.

Time frame
Baseline and 3 months of follow-up
2

Change from Baseline Heart Rate Variability at 3 months

Heart rate variability will be assessed by a heart rate monitor.

Time frame
Baseline and 3 months of follow-up

Secondary outcomes

1

Change from Baseline Heart Rate at 3 months

Heart rate will be evaluated beat-to-beat by means of a heart rate monitor.

Time frame
Baseline and 3 months of follow-up
2

Change from Baseline Peripheral Vascular Resistance at 3 months

Peripheral Vascular Resistance will be evaluated by photpletismography.

Time frame
Baseline and 3 months of follow-up
3

Change from Baseline Stroke Volume at 3 months

Stroke Volume will be evaluated by photoplethysmography.

Time frame
Baseline and 3 months of follow-up
4

Change from Baseline Cardiac Output at 3 months

Cardiac Output will be evaluated by photoplethysmography.

Time frame
Baseline and 3 months of follow-up

Other outcomes

Sponsors and contacts

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Instituto Nacional de Cardiologia de Laranjeiras

Lead sponsor

Rio de Janeiro State University

Sponsor institution

Rio de Janeiro State University

Collaborator