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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Exercise training
BehavioralExercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises.
Treatment groups
Trial outcomes
Primary outcomes
Change from Baseline Blood Pressure at 3 months
Blood pressure will be assessed by a digital sphygmomanometer.
Change from Baseline Heart Rate Variability at 3 months
Heart rate variability will be assessed by a heart rate monitor.
Secondary outcomes
Change from Baseline Heart Rate at 3 months
Heart rate will be evaluated beat-to-beat by means of a heart rate monitor.
Change from Baseline Peripheral Vascular Resistance at 3 months
Peripheral Vascular Resistance will be evaluated by photpletismography.
Change from Baseline Stroke Volume at 3 months
Stroke Volume will be evaluated by photoplethysmography.
Change from Baseline Cardiac Output at 3 months
Cardiac Output will be evaluated by photoplethysmography.
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