An interventional study of Exercise Based Cardiac Rehabilitation in Coronary Artery Disease and Coronary Heart Disease, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Health services research
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.
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:
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.
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This study's enrollment of 65 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
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.
Other: Exercise Based Cardiac Rehabilitation
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline and post-intervention (6 week later)
Plan to share: 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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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Kutahya Health Sciences University