Cardiovascular DiseasesNCT02514564
The Effects of Aerobic Exercise in Microvascular Endothelium Function in Patients With Cardiovascular Diseases
An observational study of Cardiovascular Diseases, run by Instituto Nacional de Cardiologia de Laranjeiras at 1 site in Brazil.
Trial summary
This study evaluates the effects of different volumes of aerobic exercise training in cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac rehabilitation program. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Exercise and Sedentarism
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 115 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to Dec 2016
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in the hospital in which the exercise will be performed.
Who may be able to join
- sedentarism for at least 6 months;
- clinical diagnosis for coronary artery disease (occurrence of any acute coronary syndrome, including ST elevation or non-ST elevation myocardial infarction or unstable angina or by the diagnosis of obstructive coronary artery disease on coronary angiography in patients with stable angina).
Who cannot join
- nephropathies;
- decompensated cardiovascular diseases;
- liver diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro, 21040-900
About this study
Official title: The Effects of Aerobic Exercise Training in Patients With Cardiovascular Diseases Related to Microvascular Endothelium Function, Angiogenesis, Oxidative Stress and Aerobic Capacity
This study evaluates the effects of different volumes of aerobic exercise training in cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac rehabilitation program.
Read the detailed description
Aerobic exercise training is well known to improve endothelium dependent vasodilatation in the microcirculation. However, the impact of exercise frequency on this response in patients with coronary artery disease remains unclear.
- Conditions
- Cardiovascular Diseases
- Being tested
- Exercise, Sedentarism
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Patients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols.
SedentarismBehavioural
Participants will remain sedentary.
| Study group | Role | What they receive |
|---|---|---|
| 2x/wk | This group will be consisted of patients that will perform exercise two times a week. Receives: Behavioral: Exercise | |
| 3x/wk | This group will be consisted of patients that will perform exercise three times a week. Receives: Behavioral: Exercise | |
| Control | This group will not perform exercise. Receives: Behavioral: Sedentarism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Skin microvascular blood flow
Measured through a Laser Speckle Contrast Imaging equipment
Measured: Change from baseline in skin microvascular blood flow at 6 months
Secondary outcomes (2)
Change in peak oxygen consumption
Measured at a maximal graded exercise test
Measured: Change from baseline in peak oxygen consumption at 6 months
Change in weight
Measured with a calibrated digital scale
Measured: Change from baseline in weight at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia de Laranjeiras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Pereira Borges, Instituto Nacional de Cardiologia de Laranjeiras
- Investigators
- Eduardo V Tibiriçá, PhD, Study director, Instituto Fernandes Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514564
- Sponsor's protocol ID
- Faperj-E-26/101.575
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2015
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Souza EG, De Lorenzo A, Huguenin G, Oliveira GM, Tibirica E. Impairment of systemic microvascular endothelial and smooth muscle function in individuals with early-onset coronary artery disease: studies with laser speckle contrast imaging. Coron Artery Dis. 2014 Jan;25(1):23-8. doi: 10.1097/MCA.0000000000000055.
PubMed 24172594Cordovil I, Huguenin G, Rosa G, Bello A, Kohler O, de Moraes R, Tibirica E. Evaluation of systemic microvascular endothelial function using laser speckle contrast imaging. Microvasc Res. 2012 May;83(3):376-9. doi: 10.1016/j.mvr.2012.01.004. Epub 2012 Jan 31.
PubMed 22326551Borges JP, Mediano MF, Farinatti P, Coelho MP, Nascimento PM, Lopes GO, Kopiler DA, Tibirica E. The Effects of Unsupervised Home-based Exercise Upon Functional Capacity After 6 Months of Discharge From Cardiac Rehabilitation: A Retrospective Observational Study. J Phys Act Health. 2016 Nov;13(11):1230-1235. doi: 10.1123/jpah.2016-0058. Epub 2016 Aug 24.
PubMed 27333938
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
- The Effects of Aerobic Exercise Training in Patients With Cardiovascular Diseases Related to Microvascular Endothelium Function, Angiogenesis, Oxidative Stress and Aerobic Capacity
- ClinicalTrials.gov ID
- NCT02514564
- Acronym / sponsor ID
- Faperj-E-26/101.575
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia de LaranjeirasUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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.
This study evaluates the effects of different volumes of aerobic exercise training in cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac rehabilitation program.
Detailed description
Aerobic exercise training is well known to improve endothelium dependent vasodilatation in the microcirculation. However, the impact of exercise frequency on this response in patients with coronary artery disease remains unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2x/wk | – | Behavioral: ExerciseThis group will be consisted of patients that will perform exercise two times a week. |
| 3x/wk | – | Behavioral: ExerciseThis group will be consisted of patients that will perform exercise three times a week. |
| Control | – | Behavioral: SedentarismThis group will not perform exercise. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in the hospital in which the exercise will be performed.
Key inclusion criteria (2 listed)
- sedentarism for at least 6 months;
- clinical diagnosis for coronary artery disease (occurrence of any acute coronary syndrome, including ST elevation or non-ST elevation myocardial infarction or unstable angina or by the diagnosis of obstructive coronary artery disease on coronary angiography in patients with stable angina).
Key exclusion criteria (3 listed)
- nephropathies;
- decompensated cardiovascular diseases;
- 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 |
|---|---|---|
| ExercisePatients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols. | Behavioural | 2x/wk, 3x/wk |
| SedentarismParticipants will remain sedentary. | Behavioural | Control |
Primary outcome
Changes in Skin microvascular blood flow
Time frame: Change from baseline in skin microvascular blood flow at 6 months
Measured through a Laser Speckle Contrast Imaging equipment
2 secondary outcomes
Change in peak oxygen consumption
Time frame: Change from baseline in peak oxygen consumption at 6 months
Change in weight
Time frame: Change from baseline in weight at 6 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 27 Mar 2026.
- Background: PubMed 24172594Souza EG, De Lorenzo A, Huguenin G, Oliveira GM, Tibirica E. Impairment of systemic microvascular endothelial and smooth muscle function in individuals with early-onset coronary artery disease: studies with laser speckle contrast imaging. Coron Artery Dis. 2014 Jan;25(1):23-8. doi: 10.1097/MCA.0000000000000055.
- Background: PubMed 22326551Cordovil I, Huguenin G, Rosa G, Bello A, Kohler O, de Moraes R, Tibirica E. Evaluation of systemic microvascular endothelial function using laser speckle contrast imaging. Microvasc Res. 2012 May;83(3):376-9. doi: 10.1016/j.mvr.2012.01.004. Epub 2012 Jan 31.
- Derived from this study: PubMed 27333938Borges JP, Mediano MF, Farinatti P, Coelho MP, Nascimento PM, Lopes GO, Kopiler DA, Tibirica E. The Effects of Unsupervised Home-based Exercise Upon Functional Capacity After 6 Months of Discharge From Cardiac Rehabilitation: A Retrospective Observational Study. J Phys Act Health. 2016 Nov;13(11):1230-1235. doi: 10.1123/jpah.2016-0058. Epub 2016 Aug 24.
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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.
Eduardo V Tibiriçá, PhD study director
Instituto Fernandes Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, 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 3 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 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?
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?
Changes in Skin microvascular blood flow (time frame: Change from baseline in skin microvascular blood flow at 6 months). 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 NCT02514564, which also lists 3 linked publications.
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.