HIV InfectionsNCT04512456
Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training
A study testing Exercise training in people with HIV Infections, run by Instituto Nacional de Cardiologia de Laranjeiras at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, 20550-900
Juliana Borges, 552123340775, julipborges@gmail.com
About this study
Official title: Autonomic and Hemodynamic Responses to Muscular Ergoreflex Activation in People Living With HIV/AIDS: Effects of Exercise Training.
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Exercise training
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Exercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises.
| Study group | Role | What they receive |
|---|---|---|
| Active HIV-infected patients | Experimental | Exercise training Receives: Behavioral: Exercise training |
| Inactive HIV-infected patients | No intervention | No intervention. |
| Healthy subjects | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Blood Pressure at 3 months
Blood pressure will be assessed by a digital sphygmomanometer.
Measured: 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.
Measured: Baseline and 3 months of follow-up
Secondary outcomes (7)
Change from Baseline Heart Rate at 3 months
Heart rate will be evaluated beat-to-beat by means of a heart rate monitor.
Measured: Baseline and 3 months of follow-up
Change from Baseline Peripheral Vascular Resistance at 3 months
Peripheral Vascular Resistance will be evaluated by photpletismography.
Measured: Baseline and 3 months of follow-up
Change from Baseline Stroke Volume at 3 months
Stroke Volume will be evaluated by photoplethysmography.
Measured: Baseline and 3 months of follow-up
Change from Baseline Cardiac Output at 3 months
Cardiac Output will be evaluated by photoplethysmography.
Measured: Baseline and 3 months of follow-up
Change from Baseline Blood Lactate at 3 months
Blood Lactate will be determined by the YSL 2700 analyzer.
Measured: Baseline and 3 months of follow-up.
Change from Baseline Anthropometric markers at 3 months
Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer.
Measured: Baseline and 3 months of follow-up.
Change from Baseline handgrip maximal voluntary contraction at 3 months
Handgrip maximal voluntary contraction will be assessed using a hydraulic handgrip dynamometer.
Measured: Baseline and 3 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HIV+active group will perform exercise training, while HIV+inactive and HIV- groups will not undergo intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia de Laranjeiras
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State University
- Responsible party
- Principal investigator, Juliana Pereira Borges, Rio de Janeiro State University
- Investigators
- Julana P Borges, Dr, Principal investigator, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512456
- Sponsor's protocol ID
- FAPERJ E-26/010.100935/2018
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35303017
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic and Hemodynamic Responses to Muscular Ergoreflex Activation in People Living With HIV/AIDS: Effects of Exercise Training.
- ClinicalTrials.gov ID
- NCT04512456
- Acronym / sponsor ID
- FAPERJ E-26/010.100935/2018
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia de LaranjeirasUniversity, hospital or other
- Collaborators
- Rio de Janeiro State University
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- HIV+active group will perform exercise training, while HIV+inactive and HIV- groups will not undergo intervention.
| Arm | Type | Receives |
|---|---|---|
| Active HIV-infected patients | Experimental | Behavioral: Exercise trainingExercise training |
| Inactive HIV-infected patients | No intervention | –No intervention. |
| Healthy subjects | No intervention | –No intervention. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingExercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises. | Behavioural | Active HIV-infected patients |
Primary outcome
Change from Baseline Blood Pressure at 3 months
Time frame: 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
Time frame: Baseline and 3 months of follow-up
Heart rate variability will be assessed by a heart rate monitor.
7 secondary outcomes
Change from Baseline Heart Rate at 3 months
Time frame: Baseline and 3 months of follow-up
Change from Baseline Peripheral Vascular Resistance at 3 months
Time frame: Baseline and 3 months of follow-up
Change from Baseline Stroke Volume at 3 months
Time frame: Baseline and 3 months of follow-up
Change from Baseline Cardiac Output at 3 months
Time frame: Baseline and 3 months of follow-up
Change from Baseline Blood Lactate at 3 months
Time frame: Baseline and 3 months of follow-up.
Change from Baseline Anthropometric markers at 3 months
Time frame: Baseline and 3 months of follow-up.
Change from Baseline handgrip maximal voluntary contraction at 3 months
Time frame: Baseline and 3 months of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 35303017Gama 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julana P Borges, Dr principal investigator
Rio de Janeiro State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with HIV Infections, run by Instituto Nacional de Cardiologia de Laranjeiras at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliana P Borges, Dr. (+552123340775, julipborges@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Blood Pressure at 3 months (time frame: Baseline and 3 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.