Cardiac RehabNCT07841847
Effects of Personalized Cardiac Rehabilitation on miRNAs and Biochemical Biomarkers in Patients With Coronary Artery Disease
A study testing Personalized Cardiac Rehabilitation Program in people with Cardiac Rehab and Coronary Artery Disease, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Cardiac Rehab, Coronary Artery Disease
- What is being tested?
- Personalized Cardiac Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43020
Vural KAVUNCU, Prof. Dr., 02742630043 ext. 1111, vural.kavuncu@ksbu.edu.tr
Fatima YAMAN, Assoc. Prof
About this study
Official title: Changes in Specific miRNAs and Biochemical Biomarkers Following Personalized Cardiac Rehabilitation in Patients With Coronary Artery Disease
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
- Being tested
- Personalized Cardiac Rehabilitation Program
- Keywords
- physical therapy, cardiac rehabilitation, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Cardiac Rehabilitation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Personalized Cardiac Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Secondary outcomes (6)
Change in Peak Oxygen Uptake (VO₂max)
Peak oxygen uptake will be assessed using cardiopulmonary exercise testing (CPET) performed on a cycle ergometer. VO₂max will be recorded in mL/kg/min as an indicator of maximal aerobic exercise capacity.
Measured: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Maximum Exercise Workload
Maximum exercise workload achieved during cardiopulmonary exercise testing will be recorded in watts.
Measured: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Six-Minute Walk Test Distance
Functional exercise capacity will be assessed using the Six-Minute Walk Test. Participants will be instructed to walk as far as possible without running along a 30-meter corridor for six minutes. The total distance walked will be recorded in meters.
Measured: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Resting Heart Rate
Resting heart rate will be measured before cardiopulmonary exercise testing and recorded in beats per minute.
Measured: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Maximum Heart Rate
Maximum heart rate achieved during cardiopulmonary exercise testing will be recorded in beats per minute.
Measured: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Health-Related Quality of Life
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36) before and after the cardiac rehabilitation program.
Measured: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Yaman, Kutahya Health Sciences University
- Investigators
- Vural KAVUNCU, Prof. Dr., Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841847
- Sponsor's protocol ID
- KSBÜ-CR-miRNA-
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Individual participant data will not be shared because the study includes genetic and biomarker data that may raise privacy and confidentiality concerns."
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Specific miRNAs and Biochemical Biomarkers Following Personalized Cardiac Rehabilitation in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07841847
- Acronym / sponsor ID
- KSBÜ-CR-miRNA-
- Conditions
- Cardiac Rehab, Coronary Artery Disease
- Keywords
- physical therapy, cardiac rehabilitation, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized Cardiac Rehabilitation Group | Experimental | Behavioral: Personalized Cardiac Rehabilitation ProgramParticipants 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Symptoms or signs of myocardial ischemia
- Significant left ventricular outflow tract obstruction
- Ventricular arrhythmia
- Significant valvular heart disease
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Cardiac Rehabilitation ProgramParticipants 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. | Behavioural | Personalized Cardiac Rehabilitation Group |
Primary outcome
Change in miRNA Expression Levels
Time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
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.
Change in Inflammatory, Cardiac, and Oxidative Stress Biomarkers
Time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
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.
6 secondary outcomes
Change in Peak Oxygen Uptake (VO₂max)
Time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Maximum Exercise Workload
Time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Six-Minute Walk Test Distance
Time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Resting Heart Rate
Time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Maximum Heart Rate
Time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Change in Health-Related Quality of Life
Time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. "Individual participant data will not be shared because the study includes genetic and biomarker data that may raise privacy and confidentiality concerns."
Related trials for Cardiac Rehab
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
Heart Failure, Cardiac Rehabilitation
Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
Recruiting
Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients
Cardiovascular Diseases (CVD), Coronary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vural KAVUNCU, Prof. Dr. study director
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Cardiac Rehabilitation Program in people with Cardiac Rehab and Coronary Artery Disease, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vural KAVUNCU, Prof. Dr. (90 505 777 43 06, vural.kavuncu@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in miRNA Expression Levels (time frame: Baseline and immediately after completion of the 6-8-week cardiac rehabilitation program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.