The Effects of Aerobic Exercise in Microvascular Endothelium Function in Patients With Cardiovascular Diseases

March 1, 2017 updated by: Juliana Pereira Borges, Instituto Nacional de Cardiologia de Laranjeiras

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21040-900
        • Instituto Nacional de Cardiologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated in the hospital in which the exercise will be performed.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2x/wk
This group will be consisted of patients that will perform exercise two times a week.
Behavioral: Exercise
Patients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols.
3x/wk
This group will be consisted of patients that will perform exercise three times a week.
Behavioral: Exercise
Patients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols.
Control
This group will not perform exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline in skin microvascular blood flow at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peak oxygen consumption
Time Frame: Change from baseline in peak oxygen consumption at 6 months
Measured at a maximal graded exercise test
Change from baseline in peak oxygen consumption at 6 months
Change in weight
Time Frame: Change from baseline in weight at 6 months
Measured with a calibrated digital scale
Change from baseline in weight at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia de Laranjeiras

Investigators

  • Study Director: Eduardo V Tibiriçá, PhD, Instituto Fernandes Figueira

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

August 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Faperj-E-26/101.575

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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