Coronary Artery DiseaseNCT07468955
Impact of Cardiac Rehabilitation on Patient Outcomes
A study testing Exercise Based Cardiac Rehabilitation in people with Coronary Artery Disease and Coronary Heart Disease, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aimed to retrospectively evaluate the impact of cardiac rehabilitation (CR) on functional capacity, depressive symptoms, health-related quality of life, and sleep quality in patients with heart disease. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Coronary Heart Disease
- What is being tested?
- Exercise Based Cardiac Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2019to 8 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with coronary artery disease (CAD), status post-myocardial infarction (MI), stable angina, or those who have undergone cardiac surgery
- Availability of complete pre- and post-rehabilitation clinical records, including 6-Minute Walk Test (6MWT), BDI, SF-36, and PSQI scores.
- Patients classified as stable by a cardiologist prior to the initiation of the exercise program.
Who cannot join
- Presence of severe orthopedic, neurological, or musculoskeletal disorders that prevent the performance of the 6-Minute Walk Test or exercise training.
- Patients with severe cognitive impairment
- Unstable angina pectoris, uncontrolled arrhythmias, or advanced heart failure (NYHA Class IV) that contraindicates aerobic exercise.
- Patients who dropped out of the rehabilitation program before completion or had more than a 20% absence rate in sessions.
- Patients who underwent major non-cardiac surgery within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Şehir Hastanesi Yoncalı Yerleşkesi
Kütahya, Center, 43100
About this study
Official title: The Impact of Cardiac Rehabilitation on Functional Capacity, Depression, Quality of Life, and Sleep Quality in Patients With Heart Disease: A Retrospective Study
Objective: This study aimed to retrospectively evaluate the impact of cardiac rehabilitation (CR) on functional capacity, depressive symptoms, health-related quality of life, and sleep quality in patients with heart disease.
Methods: A retrospective analysis was conducted on patients who participated in a structured CR program. Clinical records were reviewed to compare pre- and post-rehabilitation outcomes. Functional capacity was assessed using the 6-Minute Walk Test (6MWT), while depressive symptoms, health-related quality of life, and sleep quality were evaluated using the Beck Depression Inventory (BDI), the Short Form-36 (SF-36), and the Pittsburgh Sleep Quality Index (PSQI), respectively.
Read the detailed description
Background and Rationale:Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. Comprehensive cardiac rehabilitation (CR) programs are widely recognized as a cornerstone of secondary prevention, aiming to improve physical fitness, psychological well-being, and overall health status in cardiac patients. However, real-world retrospective data assessing the multi-dimensional impact of structured CR-encompassing functional capacity, psychological distress (depressive symptoms), health-related quality of life, and sleep quality-simultaneously remain crucial for optimizing patient care protocols.
Study Objectives:The primary objective of this retrospective study is to evaluate the changes in clinical, functional, and psychosocial outcomes following participation in a structured cardiac rehabilitation program. Specifically, the study aims to compare pre- and post-rehabilitation measures regarding: Functional exercise capacity, depressive symptom severity, health-related quality of life (HRQoL), sleep quality.
Study Design and Patient Population:This study utilizes a retrospective observational design. Clinical records and institutional databases will be systematically reviewed to identify patients with heart disease who were admitted to and completed a structured cardiac rehabilitation program.
Data Collection and Outcome Measures: All patient data regarding baseline characteristics, clinical history, and pre- and post-rehabilitation assessments are routinely collected as part of standard clinical care. The primary and secondary outcome measures to be extracted and analyzed include:
- Functional Capacity: Assessed using the 6-Minute Walk Test (6MWT), measuring the distance walked in 6 minutes as an indicator of submaximal aerobic capacity.
- Depressive Symptoms: Evaluated via the Beck Depression Inventory (BDI), a self-report questionnaire measuring the severity of depression.
- Health-Related Quality of Life (HRQoL): Evaluated using the Short Form-36 (SF-36) health survey, covering both physical and mental component summaries.
- Sleep Quality: Assessed using the Pittsburgh Sleep Quality Index (PSQI), measuring sleep habits and disturbances over a 1-month time interval.
Statistical Analysis: De-identified data will be analyzed using JASP statistical software. Normality of distribution for continuous variables will be tested using the Shapiro-Wilk test or Kolmogorov-Smirnov test. Paired-samples t-tests or Wilcoxon signed-rank tests will be utilized to compare pre-rehabilitation (baseline) and post-rehabilitation outcomes, depending on data normality. A p-value of < 0.05 will be considered statistically significant.
- Conditions
- Coronary Artery Disease, Coronary Heart Disease
- Being tested
- Exercise Based Cardiac Rehabilitation
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Based Cardiac RehabilitationOther
The intervention consists of a structured, exercise-based cardiac rehabilitation (CR) program. The exercise protocol was tailored to each patient's clinical status and typically included aerobic endurance training complemented by resistance training for major muscle groups. Each session lasted approximately 40-60 minutes, consisting of a 10-minute warm-up, 20-40 minutes of moderate-intensity aerobic activity or high-intensity interval training (1:1 ratio), and a 10-minute cool-down period.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation Group | Experimental | Patients in this group participated in a structured, multidisciplinary cardiac rehabilitation program. The intervention included individualized aerobic exercise training, resistance exercises, patient education, and psychosocial counseling. Receives: Other: Exercise Based Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
unctional capacity is assessed using the 6-Minute Walk Test (6MWT). The distance walked in 6 minutes is recorded in meters. An increase in distance indicates improved functional exercise capacity.
Measured: Baseline and post-intervention (6 week later)
Change in Depressive Symptom
Assessed using the Beck Depression Inventory (BDI). The BDI is a 21-item self-report scale. Scores range from 0 to 63, where higher scores indicate more severe depressive symptoms.
Measured: Baseline and post-intervention (6 week later)
Change in Quality of Life
Assessed using the Short Form-36 (SF-36) Health Survey. It consists of 36 items covering 8 dimensions of health. Scores range from 0 to 100 for each subscale, with higher scores representing better health status.
Measured: Baseline and post-intervention (6 week later)
Change in Sleep Quality
Assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 individual items generating 7 component scores. The global score ranges from 0 to 21; higher scores indicate poorer sleep quality (scores >5 suggest significant sleep disturbance).
Measured: Baseline and post-intervention (6 week later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start14 Jul 2019
- Primary completion30 Oct 2023
- Study completion8 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Okur, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468955
- Sponsor's protocol ID
- KSBU- 2023/10-13
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies regarding data privacy and the protection of sensitive patient information under national data protection laws.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cardiac Rehabilitation on Functional Capacity, Depression, Quality of Life, and Sleep Quality in Patients With Heart Disease: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07468955
- Acronym / sponsor ID
- KSBU- 2023/10-13
- Conditions
- Coronary Artery Disease, Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 14 Jul 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 8 Mar 2026 (actual)
- First posted
- 13 Mar 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.
Objective: This study aimed to retrospectively evaluate the impact of cardiac rehabilitation (CR) on functional capacity, depressive symptoms, health-related quality of life, and sleep quality in patients with heart disease.
Methods: A retrospective analysis was conducted on patients who participated in a structured CR program. Clinical records were reviewed to compare pre- and post-rehabilitation outcomes. Functional capacity was assessed using the 6-Minute Walk Test (6MWT), while depressive symptoms, health-related quality of life, and sleep quality were evaluated using the Beck Depression Inventory (BDI), the Short Form-36 (SF-36), and the Pittsburgh Sleep Quality Index (PSQI), respectively.
Detailed description
Background and Rationale:Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. Comprehensive cardiac rehabilitation (CR) programs are widely recognized as a cornerstone of secondary prevention, aiming to improve physical fitness, psychological well-being, and overall health status in cardiac patients. However, real-world retrospective data assessing the multi-dimensional impact of structured CR-encompassing functional capacity, psychological distress (depressive symptoms), health-related quality of life, and sleep quality-simultaneously remain crucial for optimizing patient care protocols.
Study Objectives:The primary objective of this retrospective study is to evaluate the changes in clinical, functional, and psychosocial outcomes following participation in a structured cardiac rehabilitation program. Specifically, the study aims to compare pre- and post-rehabilitation measures regarding: Functional exercise capacity, depressive symptom severity, health-related quality of life (HRQoL), sleep quality.
Study Design and Patient Population:This study utilizes a retrospective observational design. Clinical records and institutional databases will be systematically reviewed to identify patients with heart disease who were admitted to and completed a structured cardiac rehabilitation program.
Data Collection and Outcome Measures: All patient data regarding baseline characteristics, clinical history, and pre- and post-rehabilitation assessments are routinely collected as part of standard clinical care. The primary and secondary outcome measures to be extracted and analyzed include:
- Functional Capacity: Assessed using the 6-Minute Walk Test (6MWT), measuring the distance walked in 6 minutes as an indicator of submaximal aerobic capacity.
- Depressive Symptoms: Evaluated via the Beck Depression Inventory (BDI), a self-report questionnaire measuring the severity of depression.
- Health-Related Quality of Life (HRQoL): Evaluated using the Short Form-36 (SF-36) health survey, covering both physical and mental component summaries.
- Sleep Quality: Assessed using the Pittsburgh Sleep Quality Index (PSQI), measuring sleep habits and disturbances over a 1-month time interval.
Statistical Analysis: De-identified data will be analyzed using JASP statistical software. Normality of distribution for continuous variables will be tested using the Shapiro-Wilk test or Kolmogorov-Smirnov test. Paired-samples t-tests or Wilcoxon signed-rank tests will be utilized to compare pre-rehabilitation (baseline) and post-rehabilitation outcomes, depending on data normality. A p-value of < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation Group | Experimental | Other: Exercise Based Cardiac RehabilitationPatients in this group participated in a structured, multidisciplinary cardiac rehabilitation program. The intervention included individualized aerobic exercise training, resistance exercises, patient education, and psychosocial counseling. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with coronary artery disease (CAD), status post-myocardial infarction (MI), stable angina, or those who have undergone cardiac surgery
- Availability of complete pre- and post-rehabilitation clinical records, including 6-Minute Walk Test (6MWT), BDI, SF-36, and PSQI scores.
- Patients classified as stable by a cardiologist prior to the initiation of the exercise program.
Key exclusion criteria (5 listed)
- Presence of severe orthopedic, neurological, or musculoskeletal disorders that prevent the performance of the 6-Minute Walk Test or exercise training.
- Patients with severe cognitive impairment
- Unstable angina pectoris, uncontrolled arrhythmias, or advanced heart failure (NYHA Class IV) that contraindicates aerobic exercise.
- Patients who dropped out of the rehabilitation program before completion or had more than a 20% absence rate in sessions.
- Patients who underwent major non-cardiac surgery within the last 3 months.
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 |
|---|---|---|
| Exercise Based Cardiac RehabilitationThe intervention consists of a structured, exercise-based cardiac rehabilitation (CR) program. The exercise protocol was tailored to each patient's clinical status and typically included aerobic endurance training complemented by resistance training for major muscle groups. Each session lasted approximately 40-60 minutes, consisting of a 10-minute warm-up, 20-40 minutes of moderate-intensity aerobic activity or high-intensity interval training (1:1 ratio), and a 10-minute cool-down period. | Other | Cardiac Rehabilitation Group |
Primary outcome
Functional Capacity
Time frame: Baseline and post-intervention (6 week later)
unctional capacity is assessed using the 6-Minute Walk Test (6MWT). The distance walked in 6 minutes is recorded in meters. An increase in distance indicates improved functional exercise capacity.
Change in Depressive Symptom
Time frame: Baseline and post-intervention (6 week later)
Assessed using the Beck Depression Inventory (BDI). The BDI is a 21-item self-report scale. Scores range from 0 to 63, where higher scores indicate more severe depressive symptoms.
Change in Quality of Life
Time frame: Baseline and post-intervention (6 week later)
Assessed using the Short Form-36 (SF-36) Health Survey. It consists of 36 items covering 8 dimensions of health. Scores range from 0 to 100 for each subscale, with higher scores representing better health status.
Change in Sleep Quality
Time frame: Baseline and post-intervention (6 week later)
Assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 individual items generating 7 component scores. The global score ranges from 0 to 21; higher scores indicate poorer sleep quality (scores >5 suggest significant sleep disturbance).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies regarding data privacy and the protection of sensitive patient information under national data protection laws.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Based Cardiac Rehabilitation in people with Coronary Artery Disease and Coronary Heart 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: Baseline and post-intervention (6 week later)). The study lists 4 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 30 Jul 2026.