NCT02514564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

July 30, 2015

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in peak oxygen consumption

    Change from baseline in peak oxygen consumption at 6 months

  • Change in weight

    Change from baseline in weight at 6 months

Study Arms (3)

2x/wk

This group will be consisted of patients that will perform exercise two times a week.

Behavioral: Exercise

3x/wk

This group will be consisted of patients that will perform exercise three times a week.

Behavioral: Exercise

Control

This group will not perform exercise.

Behavioral: Sedentarism

Interventions

SedentarismBEHAVIORAL

Participants will remain sedentary.

Control
ExerciseBEHAVIORAL

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

2x/wk3x/wk

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • nephropathies;
  • decompensated cardiovascular diseases;
  • liver diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, 21040-900, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 24172594BACKGROUND
  • 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.

    PMID: 22326551BACKGROUND
  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for nitrite/nitrate quantification.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eduardo V Tibiriçá, PhD

    Instituto Fernandes Figueira

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 3, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations