HIV/AIDSNCT03343522
The Effects of Exercise Training in Vascular Function of Patients Living With HIV
A study testing Exercise in people with HIV/AIDS, run by Instituto Nacional de Cardiologia de Laranjeiras at 1 site in Brazil.
Trial summary
Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear that the aerobic exercise training induces improvements in autonomic control and vascular function, through increases in vasodilator… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Nov 2017to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sedentarism for at least 6 months;
- diagnosis of HIV infection.
Who cannot join
- opportunistic diseases;
- nephropathies;
- cardiovascular diseases;
- locomotor limitations;
- liver diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, 20550-900
About this study
Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear that the aerobic exercise training induces improvements in autonomic control and vascular function, through increases in vasodilator agents and blood vessels number. However, the investigators could not find previous works that studied the microvascular function in response to exercise training in HIV patients.
Objectives: To study the impact of aerobic exercise training in endothelial function of HIV patients. In addition, the investigators will verify the association of the physical fitness to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients.
Read more
Methods: The study subjects will be composed by HIV patients, that will be randomly divided in two different groups: exercised and sedentary. The subjects will be tested before and after training in regards to endothelial function, nitric oxide bioavailability, physical fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary exercise test, and biochemical tests; respectively. The exercise training will be performed in a treadmill for 12 weeks, 3 times a week, 40 minutes each section.
Expected Results: The investigators expect to achieve markers that will help in understanding the interaction of HIV with several factors that contribute to an increased endothelial function after exercise training.
Read the detailed description
HIV-infection triggers a massive oxygen reactive species production, increasing oxidative stress and vascular complications. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among HIV-infected patients (HIVP), exercise-related effects upon macro-and-microvascular endothelial function and oxidative stress in HIVP have not been previously reported.
- Conditions
- HIV/AIDS
- Being tested
- Exercise
- Keywords
- Vascular function, Physical training, Laser Speckle Contrast Imaging
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).
| Study group | Role | What they receive |
|---|---|---|
| Sedentarism | No intervention | Patients assigned to this arm shall not perform regular exercise training. |
| Exercise Training | Experimental | Patients assigned to this arm will be enrolled in exercise training program. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin microvascular blood flow
Microvascular reactivity will be evaluated by laser speckle contrast imaging with laser wavelength of 785 nm in combination with iontophoresis of acetylcholine (ACh) and sodium nitroprusside (SNP) for noninvasive and continuous measurements of cutaneous microvascular flow changes in the forearm.
Measured: Baseline and 3 months
Secondary outcomes (5)
Peak Oxygen consumption
Measured at a maximal graded exercise test.
Measured: Baseline and 3 months
Nitrite/nitrate
Colorimetric assay kit
Measured: Baseline and 3 months
Body fat
Dual-energy X-ray absorptiometry.
Measured: Baseline and 3 months
Forearm macrovascular blood flow
Forearm macrovascular blood flow will be evaluated by venous occlusion plethysmography.
Measured: Baseline and 3 months
Capillary density
Capillary density will be evaluated by high-resolution intra-vital color microscopy.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start10 Nov 2017
- Primary completion20 Dec 2022
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
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, Instituto Nacional de Cardiologia de Laranjeiras
- Investigators
- Juliana P Borges, PhD, Principal investigator, Insituto Nacional de Cardiologia and Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343522
- Sponsor's protocol ID
- CAAE42162815.5.0000.5272
- Status last verified
- Mar 2023
- First submitted
- 10 Nov 2017
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Training in Vascular Function of Patients Living With HIV
- ClinicalTrials.gov ID
- NCT03343522
- Acronym / sponsor ID
- CAAE42162815.5.0000.5272
- Conditions
- HIV/AIDS
- Keywords
- Vascular function, Physical training, Laser Speckle Contrast Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia de LaranjeirasUniversity, hospital or other
- Collaborators
- Rio de Janeiro State University
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 17 Nov 2017 (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.
Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear that the aerobic exercise training induces improvements in autonomic control and vascular function, through increases in vasodilator agents and blood vessels number. However, the investigators could not find previous works that studied the microvascular function in response to exercise training in HIV patients.
Objectives: To study the impact of aerobic exercise training in endothelial function of HIV patients. In addition, the investigators will verify the association of the physical fitness to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients.
Methods: The study subjects will be composed by HIV patients, that will be randomly divided in two different groups: exercised and sedentary. The subjects will be tested before and after training in regards to endothelial function, nitric oxide bioavailability, physical fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary exercise test, and biochemical tests; respectively. The exercise training will be performed in a treadmill for 12 weeks, 3 times a week, 40 minutes each section.
Expected Results: The investigators expect to achieve markers that will help in understanding the interaction of HIV with several factors that contribute to an increased endothelial function after exercise training.
Detailed description
HIV-infection triggers a massive oxygen reactive species production, increasing oxidative stress and vascular complications. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among HIV-infected patients (HIVP), exercise-related effects upon macro-and-microvascular endothelial function and oxidative stress in HIVP have not been previously reported.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentarism | No intervention | –Patients assigned to this arm shall not perform regular exercise training. |
| Exercise Training | Experimental | Behavioral: ExercisePatients assigned to this arm will be enrolled in exercise training program. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sedentarism for at least 6 months;
- diagnosis of HIV infection.
Key exclusion criteria (5 listed)
- opportunistic diseases;
- nephropathies;
- cardiovascular diseases;
- locomotor limitations;
- liver diseases.
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 |
|---|---|---|
| ExerciseA multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity). | Behavioural | Exercise Training |
Primary outcome
Skin microvascular blood flow
Time frame: Baseline and 3 months
Microvascular reactivity will be evaluated by laser speckle contrast imaging with laser wavelength of 785 nm in combination with iontophoresis of acetylcholine (ACh) and sodium nitroprusside (SNP) for noninvasive and continuous measurements of cutaneous microvascular flow changes in the forearm.
5 secondary outcomes
Peak Oxygen consumption
Time frame: Baseline and 3 months
Nitrite/nitrate
Time frame: Baseline and 3 months
Body fat
Time frame: Baseline and 3 months
Forearm macrovascular blood flow
Time frame: Baseline and 3 months
Capillary density
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- 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. This study is not recruiting at the moment.
Juliana P Borges, PhD principal investigator
Insituto Nacional de Cardiologia and 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 in people with HIV/AIDS, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 7 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin microvascular blood flow (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2023.