- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468955
Impact of Cardiac Rehabilitation on Patient Outcomes
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, and the quality of life and sleep 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Center
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Kütahya, Center, Turkey (Türkiye), 43100
- Kutahya Şehir Hastanesi Yoncalı Yerleşkesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Cardiac Rehabilitation Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Capacity
Time Frame: Baseline and and post-intervention (6 week later)
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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.
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Baseline and and post-intervention (6 week later)
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Change in Depressive Symptom
Time Frame: Baseline and and post-intervention (6 week later)
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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.
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Baseline and and post-intervention (6 week later)
|
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Change in Quality of Life
Time Frame: Baseline and and post-intervention (6 week later)
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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.
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Baseline and and post-intervention (6 week later)
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Change in Sleep Quality
Time Frame: Baseline and and post-intervention (6 week later)
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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).
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Baseline and and post-intervention (6 week later)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSBU- 2023/10-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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