HIV Infections
Conditions
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.
Interventions
BEHAVIORALExercise training
Exercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises.
Sponsors
Instituto Nacional de Cardiologia de Laranjeiras
Rio de Janeiro State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
HIV+active group will perform exercise training, while HIV+inactive and HIV- groups will not undergo intervention.
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Blood Pressure at 3 months | Baseline and 3 months of follow-up | Blood pressure will be assessed by a digital sphygmomanometer. |
| Change from Baseline Heart Rate Variability at 3 months | Baseline and 3 months of follow-up | Heart rate variability will be assessed by a heart rate monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Heart Rate at 3 months | Baseline and 3 months of follow-up | Heart rate will be evaluated beat-to-beat by means of a heart rate monitor. |
| Change from Baseline Peripheral Vascular Resistance at 3 months | Baseline and 3 months of follow-up | Peripheral Vascular Resistance will be evaluated by photpletismography. |
| Change from Baseline Stroke Volume at 3 months | Baseline and 3 months of follow-up | Stroke Volume will be evaluated by photoplethysmography. |
| Change from Baseline Cardiac Output at 3 months | Baseline and 3 months of follow-up | Cardiac Output will be evaluated by photoplethysmography. |
| Change from Baseline Blood Lactate at 3 months | Baseline and 3 months of follow-up. | Blood Lactate will be determined by the YSL 2700 analyzer. |
| Change from Baseline Anthropometric markers at 3 months | Baseline and 3 months of follow-up. | Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer. |
| Change from Baseline handgrip maximal voluntary contraction at 3 months | Baseline and 3 months of follow-up. | Handgrip maximal voluntary contraction will be assessed using a hydraulic handgrip dynamometer. |
Countries
Brazil
Contacts
CONTACTJuliana P Borges, Dr.
CONTACTGabriel S Gama
PRINCIPAL_INVESTIGATORJulana P Borges, Dr
Rio de Janeiro State University
Outcome results
None listed