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Completed

NCT Number: NCT07468955

Impact of Cardiac Rehabilitation on Patient Outcomes

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Şehir Hastanesi Yoncalı Yerleşkesi

Kütahya, Center, 43100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Exercise Based Cardiac Rehabilitation

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

The Impact of Cardiac Rehabilitation on Functional Capacity, Depression, Quality of Life, and Sleep Quality in Patients With Heart Disease: A Retrospective Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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