Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
All Genders
Healthy Volunteers
ID06579807

Effect of a Cardiovascular Rehabilitation Program on Atherosclerosis, Endothelial Function and Inflammation in Patients With Coronary Artery Disease

Led by Instituto Nacional de Cardiologia de Laranjeiras · Updated on 2026-03-27

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Instituto Nacional de Cardiologia de Laranjeiras

Lead Sponsor

R

Rio de Janeiro State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of a cardiovascular rehabilitation program on patients with coronary artery disease (CAD) aged 40 to 70 years. The study compares these patients with a reference group of healthy individuals matched by age and physical activity level. The purpose is to assess changes in artery thickness, endothelial function, inflammation, and metabolic biomarkers related to CAD. Participants include 28 CAD patients and 22 healthy controls, with evaluations conducted before and after a 12-week exercise intervention. The intervention involves a supervised exercise program combining aerobic, resistance, and flexibility training, conducted three times per week for 12 weeks. Each session lasts 60 minutes, with aerobic exercises performed at moderate intensity on a treadmill or stationary bike, and resistance exercises targeting major muscle groups. Healthy controls do not receive any intervention and serve as a comparison group. Assessments take place at two visits: the first includes carotid artery ultrasound and cardiopulmonary exercise testing, while the second assesses vascular function and collects blood samples before and after moderate aerobic exercise. Participants attend two assessment visits at baseline and after the 12-week program, with at least 72 hours between visits. During visits, medical history, artery thickness, vascular function, and blood biomarkers related to inflammation, endothelial injury, and kynurenine pathway metabolites are measured. Exercise performance and oxygen consumption are also evaluated. The study monitors safety and adherence through standardized procedures and controlled environmental conditions. Total participation spans the 12-week intervention and follow-up assessments.

CONDITIONS

Brief Title

Cardiac Rehabilitation and Coronary Artery Disease

Who Can Participate

Age: 40Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 to 70 years
  • Diagnosed with coronary artery disease including acute coronary syndrome or obstructive CAD
  • Both male and female participants
  • Healthy adults aged 40 to 70 years without coronary artery disease as controls
  • Participants entering the cardiac rehabilitation program at HUPE
  • Matched by age and physical activity level between groups
Not Eligible

You will not qualify if you...

  • Diagnosis of heart failure, pulmonary disease, Chagas disease, or tuberculosis
  • Regular physical exercise (3 or more days per week for 30 minutes) in the past 6 months
  • Malnutrition with body mass index less than 18.5 kg/m²
  • Current smoking
  • Obesity with body mass index 30 kg/m² or higher

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants in the exercise training group undergo a 12-week supervised multimodal exercise program including aerobic, resistance, and flexibility exercises, performed in 3 weekly sessions lasting 60 minutes each.

3 exercise sessions per week (in-person)

Assessment Visits

Duration - 2 visits over the study period

Participants attend two assessment visits at baseline and after the 12-week intervention to evaluate carotid intima-media thickness, cardiopulmonary exercise testing, blood biomarkers, vascular function, and maximal oxygen consumption.

2 visits (in-person) separated by at least 72 hours

Trial Site Locations

Total: 1 location

1

Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, Brazil, 20550-900

Actively Recruiting

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Research Team

J

Juliana Borges, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Acute and chronic effects of physical exercise on atherosclerosis, kynurenine pathway, endothelial function and inflammation in patients with coronary artery disease: a clinical trial protocol.

Gabriela Andrade Paz, Marcus Vds Rangel, Caio Luan Farias...

https://pubmed.ncbi.nlm.nih.gov/39944998