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

NCT04512456 | Recruiting DMC

• 1 other identifier: FAPERJ E-26/010.100935/2018
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Blood Pressure at 3 months

  Blood pressure will be assessed by a digital sphygmomanometer.

  Baseline and 3 months of follow-up

• Change from Baseline Heart Rate Variability at 3 months

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

  Baseline and 3 months of follow-up

Secondary Outcomes (7)

• Change from Baseline Heart Rate at 3 months

  Baseline and 3 months of follow-up

• Change from Baseline Peripheral Vascular Resistance at 3 months

  Baseline and 3 months of follow-up

• Change from Baseline Stroke Volume at 3 months

  Baseline and 3 months of follow-up

• Change from Baseline Cardiac Output at 3 months

  Baseline and 3 months of follow-up

• Change from Baseline Blood Lactate at 3 months

  Baseline and 3 months of follow-up.

Study Arms (3)

Active HIV-infected patients

EXPERIMENTAL

Exercise training

Behavioral: Exercise training

Inactive HIV-infected patients

NO INTERVENTION

No intervention.

Healthy subjects

NO INTERVENTION

No intervention.

Interventions

Exercise training BEHAVIORAL

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

Active HIV-infected patients

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia de Laranjeiras: lead
• Rio de Janeiro State University: collaborator

Study Sites (1)

Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, 20550-900, Brazil

RECRUITING

Related Publications (1)

• Gama G, Dos Santos Rangel MV, de Oliveira Coelho VC, Paz GA, de Matos CVB, Silva BP, Lopes GO, Lopes KG, Farinatti P, Borges JP. The effects of exercise training on autonomic and hemodynamic responses to muscle metaboreflex in people living with HIV/AIDS: A randomized clinical trial protocol. PLoS One. 2022 Mar 18;17(3):e0265516. doi: 10.1371/journal.pone.0265516. eCollection 2022.

  PMID: 35303017 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Julana P Borges, Dr

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana P Borges, Dr.

CONTACT

+552123340775; julipborges@gmail.com

Gabriel S Gama

CONTACT

+552123340775; profgabrielgama@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 13, 2020
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)