Effects of Personalized Cardiac Rehabilitation on miRNAs and Biochemical Biomarkers in Patients With Coronary Artery Disease

NCT07841847 | Not Yet Recruiting

• 1 other identifier: KSBÜ-CR-miRNA-
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective interventional study aims to investigate changes in specific microRNAs (miRNAs) and biochemical biomarkers following a personalized cardiac rehabilitation program in patients with coronary artery disease. A total of 46 participants aged 35-75 years who have undergone percutaneous coronary intervention or coronary artery bypass graft surgery and are eligible for cardiac rehabilitation will be included. Participants will complete a structured, individualized cardiac rehabilitation program lasting 6-8 weeks. Clinical assessments, cardiopulmonary exercise testing, and blood-based biomarker measurements will be performed before and after the rehabilitation program. The primary objective is to determine changes in miRNA and biochemical biomarker levels after cardiac rehabilitation and to evaluate the relationship between these changes and clinical improvement. The findings may contribute to a better understanding of biological responses to cardiac rehabilitation and support the development of more personalized rehabilitation strategies.

Conditions

Cardiac Rehab; Coronary Artery Disease

Keywords

physical therapy; cardiac rehabilitation; coronary artery disease

Outcome Measures

Primary Outcomes (2)

• Change in miRNA Expression Levels

  Changes in the expression levels of miR-21, miR-126, miR-92a, miR-1, miR-155, and miR-133a will be assessed using quantitative real-time polymerase chain reaction (qRT-PCR) before and after completion of the cardiac rehabilitation program.

  Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

• Change in Inflammatory, Cardiac, and Oxidative Stress Biomarkers

  Changes in circulating levels of NT-proBNP, troponins, hs-CRP, IL-6, TNF-α, ST2, semaphorins, MDA, ADMA, and eNOS will be assessed before and after the cardiac rehabilitation program.

  Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

Secondary Outcomes (6)

• Change in Peak Oxygen Uptake (VO₂max)

  Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

• Change in Maximum Exercise Workload

  Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

• Change in Six-Minute Walk Test Distance

  Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

• Change in Resting Heart Rate

  Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

• Change in Maximum Heart Rate

  Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program

Study Arms (1)

Personalized Cardiac Rehabilitation Group

EXPERIMENTAL

Participants will undergo a structured, individualized cardiac rehabilitation program lasting 6-8 weeks. Exercise intensity and workload will be prescribed according to each participant's baseline cardiopulmonary exercise test results, including peak oxygen uptake and maximal workload. The rehabilitation program will be tailored to the participant's clinical status and exercise capacity. Clinical assessments, cardiopulmonary exercise testing, and blood sampling for miRNA and biochemical biomarker analyses will be performed before and after completion of the rehabilitation program.

Behavioral: Personalized Cardiac Rehabilitation Program

Interventions

Personalized Cardiac Rehabilitation Program BEHAVIORAL

Participants will receive a structured, individualized cardiac rehabilitation program consisting of 30 supervised aerobic exercise sessions performed on a cycle ergometer. Each session will last approximately 45-60 minutes and will include a 5-10-minute low-intensity warm-up, an individualized aerobic exercise phase, and a gradual cool-down period. Exercise intensity will be prescribed according to baseline cardiopulmonary exercise testing and maximal exercise capacity. Training intensity will begin at approximately 40-50% of VO₂max, progress to 60-70% of VO₂max corresponding to a Borg Rating of Perceived Exertion of approximately 12-15, and may reach approximately 80% of VO₂max when clinically appropriate and well tolerated. Exercise workload will be individualized based on the maximal workload achieved during baseline cardiopulmonary exercise testing.

Personalized Cardiac Rehabilitation Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable coronary artery disease
• History of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
• Referred and considered clinically eligible for a structured cardiac rehabilitation program
• Achievement of a respiratory quotient (RQ) of at least 1.0 during the baseline cardiopulmonary exercise test
• Ability and willingness to participate in the study and complete the cardiac rehabilitation program

You may not qualify if:

• Symptoms or signs of myocardial ischemia
• Significant left ventricular outflow tract obstruction
• Ventricular arrhythmia
• Significant valvular heart disease
• Uncontrolled hypertension
• Severe comorbid conditions, including end-stage renal disease, advanced liver disease, or chronic inflammatory disease
• Active malignancy
• Physical limitations preventing full participation in exercise, including severe musculoskeletal disorders or major orthopedic or neurological comorbidities
• Body mass index greater than 35 kg/m²
• History of orthopedic surgery within the previous 6 months
• Failure to comply with exercise testing or training procedures, or attendance of less than 80% of the rehabilitation program
• Use of medications known to directly alter miRNA expression, such as certain immunosuppressive agents or chemotherapy drugs
• Known psychiatric disorder
• Presence of a permanent cardiac pacemaker

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Vural KAVUNCU, Prof. Dr.

  Kutahya Health Sciences University

  STUDY DIRECTOR

Central Study Contacts

Vural KAVUNCU, Prof. Dr.

CONTACT

90 505 777 43 06; vural.kavuncu@ksbu.edu.tr

Meltem ÇOBAN, Dr.

CONTACT

+90 544 284 42 58; meltem.368@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)