Clinical trial NCT02514564: The Effects of Aerobic Exercise in Microvascular Endothelium Function in Patients With Cardiovascular Diseases
Official title: The Effects of Aerobic Exercise Training in Patients With Cardiovascular Diseases Related to Microvascular Endothelium Function, Angiogenesis, Oxidative Stress and Aerobic Capacity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: Instituto Nacional de Cardiologia de Laranjeiras
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 115
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the hospital in which the exercise will be performed.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Skin microvascular blood flow
timeFrame: Change from baseline in skin microvascular blood flow at 6 months
Secondary outcomes:
measure: Change in peak oxygen consumption
timeFrame: Change from baseline in peak oxygen consumption at 6 months
measure: Change in weight
timeFrame: Change from baseline in weight at 6 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cardiologia
state: RJ
Study officials:
affiliation: Instituto Fernandes Figueira
name: Eduardo V Tibiriçá, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Cordovil 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.
citation: Borges 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.