Cardiac Rehabilitation and Coronary Artery Disease

NCT06579807 | Recruiting

• 1 other identifier: 404204/2023-6
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Atherosclerosis

Keywords

Cardiac rehabilitation; Physical training; Inflammation; Intercellular adhesion molecules

Outcome Measures

Primary Outcomes (1)

• Carotid intima-media thickness

  The assessment of the intima-media thickness (IMT) of the left and right common carotid arteries will be performed with the patient in the supine position, with the head turned to the side (45°), using a portable ultrasound device (Logiq-e, GE HealthCare, Boston, MA, USA) with a 9 L linear probe (12 MHz).

  Baseline and 12 weeks

Secondary Outcomes (5)

• Blood biomarkers of kynurenine pathway metabolites

  Baseline and 12 weeks

• Blood biomarkers of inflammation

  Baseline and 12 weeks

• Blood biomarkers of endothelial injury

  Baseline and 12 weeks

• Vascular function

  Baseline and 12 weeks

• Maximal oxygen consumption

  Baseline and 12 weeks

Study Arms (2)

Exercise training

EXPERIMENTAL

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

Behavioral: Exercise training

Control healthy

NO INTERVENTION

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

Interventions

Exercise training 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).

Exercise training

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rio de Janeiro State University: collaborator
• Instituto Nacional de Cardiologia de Laranjeiras: lead

Study Sites (1)

Rio de Janeiro State University

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

RECRUITING

Related Publications (1)

• 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.

  PMID: 39944998 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Inflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juliana Borges, PhD

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Borges, PhD

CONTACT

+55212234; juliana.borges@uerj.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 30, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)