Cardiac Rehabilitation and Coronary Artery Disease

NCT ID: NCT06579807

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-12-31

Brief Summary

Patients with coronary artery disease (CAD) aged 40-70 years will undergo exercise training (thrice weekly for 12 weeks). A reference group composed of healthy individuals will be included. Evaluations will be conducted at baseline and after the intervention period during two visits. During the first visit, carotid artery thickness will be assessed via ultrasound before and after a cardiopulmonary exercise testing. The second visit will include the evaluation of endothelial function using venous occlusion plethysmography. After this, participants will engage in 30 minutes of moderate-intensity aerobic exercise, and blood samples will be collected pre- and post-exercise. Circulating levels of kynurenine pathway (KP) metabolites (Tryptophan, kynurenine, kynurenic acid, and quinolinic acid), pro-inflammatory cytokines, cell adhesion molecules, and lipid profiles will be measured via Enzyme-Linked Immunosorbent Assay (ELISA), multiplex essays, and biochemical analysis; respectively.

Detailed Description

Participants and recruitment: In this clinical trial, 28 patients with CAD will be enrolled from the Pedro Ernesto University Hospital (HUPE) and 22 control volunteers without evidence of CAD (CTL) will be randomly recruited from among employees and students at the University of Rio de Janeiro State (UERJ). The groups will be matched by age and habitual physical activity level, assessed by the Baecke questionnaire, which quantifies activities performed at home, work, and leisure (sports).

All participants will receive oral and written instructions regarding the risks and benefits of the study and will provide written informed consent. The study was approved by the Research Ethics Committee of HUPE (CAAE 81718324.3.0000.5259). The study also adheres to SPIRIT 2013 (Standard Protocol Items: Recommendations for International Trials).

Study design: Evaluations will be conducted at baseline and after the 12-week intervention period during two visits interspersed by at least 72-hours interval. Outcomes in the CTL group will be assessed only at baseline to provide reference values. Visits will take place at the Physical Activity and Health Promotion Laboratory (LABSAU) and the Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc), always in the morning (8:00 - 11:00 am), in rooms with controlled temperatures between 22°-24°C and relative humidity between 60-70%. Participants will be instructed to avoid physical activity, alcohol, and stimulants 48 hours prior to assessments.

During the first visit, volunteers will undergo a medical history assessment. If eligible, they will read and sign the informed consent form, if they agree to participate. Subsequently, carotid intima-media thickness will be assessed via carotid ultrasound, followed by a cardiopulmonary exercise testing (CPET). Immediately after the test, carotid intima-media thickness will be reassessed.

On the second visit, patients will undergo blood collection after 8 hours of fasting, followed by an assessment of vascular function using venous occlusion plethysmography. Approximately 15 min after a light standardized breakfast, participants will engage in 30 minutes of moderate-intensity aerobic exercise, after which blood samples will be collected again.

Conditions

Coronary Artery Disease; Atherosclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise training

The multimodal supervised exercise program will include aerobic, resistance, and flexibility exercises during 12 weeks, performed in 3 weekly sessions lasting 60 minutes each.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

The multimodal supervised exercise program will include aerobic, resistance, and flexibility exercises. The training program will last 12 weeks, performed in 3 weekly sessions lasting 60 minutes each. Aerobic exercise, lasting between 20-30 minutes, will be conducted on a treadmill or stationary bike at an intensity ranging from 75-85% of the maximal heart rate (HR), based on the cardiopulmonary exercise testing. Resistance training, lasting 30 minutes, will include 8 to 10 exercises performed in 3 sets of 10 to 12 maximum repetitions with 1-minute intervals, targeting major muscle groups of the upper and lower limbs, with loads corresponding to 80-90% of the 10-repetitions maximum (RM).

Control healthy

A reference group composed of healthy individuals without intervention will be included.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

The multimodal supervised exercise program will include aerobic, resistance, and flexibility exercises. The training program will last 12 weeks, performed in 3 weekly sessions lasting 60 minutes each. Aerobic exercise, lasting between 20-30 minutes, will be conducted on a treadmill or stationary bike at an intensity ranging from 75-85% of the maximal heart rate (HR), based on the cardiopulmonary exercise testing. Resistance training, lasting 30 minutes, will include 8 to 10 exercises performed in 3 sets of 10 to 12 maximum repetitions with 1-minute intervals, targeting major muscle groups of the upper and lower limbs, with loads corresponding to 80-90% of the 10-repetitions maximum (RM).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Eligible CAD patients will be those aged 40 to 70 years, of both sexes, entering the cardiac rehabilitation program at HUPE. CAD will be defined as any acute coronary syndrome, including myocardial infarction with and without ST-segment elevation, and unstable angina (all defined by characteristic histories, electrocardiographic abnormalities, and cardiac enzyme abnormalities), or obstructive CAD diagnosed via coronary angiography (defined as ≥ 50% stenosis of any epicardial coronary artery) in patients with stable angina.
• Healthy controls: adults aged 40 to 70 years, of both sexes, without CAD evidence.

Exclusion Criteria

• diagnosis of heart failure, pulmonary disease, Chagas disease, or tuberculosis
• regular physical exercise practice (≥ 3 days/week for 30 min) over the past 6 months
• malnutrition (body mass index [BMI] < 18.5 kg/m²)
• smoking
• obesity (BMI ≥ 30 kg/m²)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: collaborator

Instituto Nacional de Cardiologia de Laranjeiras

OTHER

Sponsor Role: lead

Responsible Party

Juliana Pereira Borges

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliana Borges, PhD

Role: PRINCIPAL_INVESTIGATOR

Rio de Janeiro State University

Locations

Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Juliana Borges, PhD

Role: CONTACT

juliana.borges@uerj.br

+55212234 ext. 0775

Facility Contacts

Juliana P Borges, PhD

Role: primary

julipborges@gmail.com

55 21 25620775

Gabriella O Lopes

Role: backup

gabriella.olopes@hotmail.com

55 21 979576950

References

Paz GA, Rangel MV, Farias CL, Soares ALC, Langner E, Teixeira T, Dutra PML, Bouskela E, Farinatti P, Souza MDGC, Borges JP. 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. BMJ Open Sport Exerc Med. 2025 Feb 10;11(1):e002432. doi: 10.1136/bmjsem-2024-002432. eCollection 2025.

Reference Type: DERIVED

PMID: 39944998 (View on PubMed)

Other Identifiers

404204/2023-6

Identifier Type: -

Identifier Source: org_study_id