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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02514564
Other study ID # Faperj-E-26/101.575
Secondary ID
Status Completed
Phase N/A
First received July 30, 2015
Last updated March 1, 2017
Start date December 2014
Est. completion date December 2016

Study information

Verified date March 2017
Source Instituto Nacional de Cardiologia de Laranjeiras
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- nephropathies;

- decompensated cardiovascular diseases;

- liver diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
Patients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols.

Locations

Country Name City State
Brazil Instituto Nacional de Cardiologia Rio de Janeiro RJ

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Cardiologia de Laranjeiras

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Cordovil I, Huguenin G, Rosa G, Bello A, Köhler O, de Moraes R, Tibiriçá 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. — View Citation

Souza EG, De Lorenzo A, Huguenin G, Oliveira GM, Tibiriçá 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Skin microvascular blood flow Measured through a Laser Speckle Contrast Imaging equipment Change from baseline in skin microvascular blood flow at 6 months
Secondary Change in peak oxygen consumption Measured at a maximal graded exercise test Change from baseline in peak oxygen consumption at 6 months
Secondary Change in weight Measured with a calibrated digital scale Change from baseline in weight at 6 months
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