NCT04512456 Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training
| NCT ID | NCT04512456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Cardiologia de Laranjeiras |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 63 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Julana P Borges, Dr
PRINCIPAL INVESTIGATOR
Rio de Janeiro State University
Frequently Asked Questions
Who can join the NCT04512456 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 50 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04512456 currently recruiting?
Yes, NCT04512456 is actively recruiting participants. Contact the research team at julipborges@gmail.com for enrollment information.
Where is the NCT04512456 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT04512456 clinical trial?
NCT04512456 is sponsored by Instituto Nacional de Cardiologia de Laranjeiras. The principal investigator is Julana P Borges, Dr at Rio de Janeiro State University. The trial plans to enroll 63 participants.
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