Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery
Effect of Cardiac Rehabilitation Program on Quality of Life, Sleep Quality, Anxiety, Depression and Cardiopulmonary Function After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial
1 other identifier
interventional
28
1 country
1
Brief Summary
This study aimed to evaluate the effects of cardiac rehabilitation program after CABG surgery on quality of life, sleep quality, anxiety, depression and cardiopulmonary functions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2025
CompletedFirst Submitted
Initial submission to the registry
May 5, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedMay 14, 2025
May 1, 2025
4 months
May 5, 2025
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Evaluation of quality of life of groups
SF-36 quality of life scale: Contains 36 items. Measurement of 8 dimensions is provided. These dimensions are: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain and general health perception.
ıt ranges from 3 months to 6 months
Evaluation of sleep quality of groups
Pittsburgh Sleep Quality Index: Contains 24 questions in total. 19 of these are self-report questions. Five questions are answered by the spouse or a roommate and are used for clinical information only. They are not included in the scoring. It has seven components. These components are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. Each item is scored between 0-3. A total score of 5 or higher indicates poor sleep quality.
ıt ranges 3 months to 6 months
Evaluation of depression and anxiety of groups
Beck Depression Scale: Consists of 21 questions. Each question has 4 answer options scored between 0 and 3. A total score between 0-13 indicates no depression, 14-19 indicates mild depression, 20-18 indicates moderate depression, and 29-63 indicates severe depression. Beck Anxiety Scale: Consists of 21 questions. Questions are scored between 0-3. The minimum score on the scale is 0, the maximum score is 63. Increasing scores on the scale indicate an increase in the anxiety level.
ıt ranges 3 months to 6 months
Evaluation of cardiopulmonary functions of groups
6-minute walking test: It is applied in a 30-meter corridor in a closed environment. The distance the patient walks in six minutes, oxygen saturation, heart rate, and changes in dyspnea are recorded. FEV1, FVC and FEV1/FVC values with respiratory function test, echo test for ejection fraction, blood test for LDL values, height and weight values for body mass index
ıt ranges 3 months to 6 months
Study Arms (2)
Comparison of the effects of cardiac rehabilitation programs on patient outcomes
EXPERIMENTALThe experimental group patients were included in the cardiac rehabilitation program. The cardiac rehabilitation program was implemented in the cardiopulmonary rehabilitation unit with bicycle ergometry devices by a team consisting of a physical medicine and rehabilitation physician, physiotherapist and nurse. The target heart rate that could be achieved during exercise was determined according to the patient's age and the medications he/she used. The exercise intensity was planned as low and moderate according to the target heart rate percentage. The program was organized as 30 sessions, 5 days a week, for 6 weeks. The sessions were implemented for half an hour while the patients were monitored from the bicycle ergometry device.
Comparison of the effects of standard care on patient outcomes
NO INTERVENTIONThe control group patients were not subjected to any program other than the training they received upon discharge, which was the routine operation of the clinics.
Interventions
The experimental group patients were included in the cardiac rehabilitation program. The cardiac rehabilitation program was implemented in the cardiopulmonary rehabilitation unit with bicycle ergometry devices by a team consisting of a physical medicine and rehabilitation physician, physiotherapist and nurse. The target heart rate that could be achieved during exercise was determined according to the patient's age and the medications he/she used. The exercise intensity was planned as low and moderate according to the target heart rate percentage. The program was organized as 30 sessions, 5 days a week, for 6 weeks. The sessions were implemented for half an hour while the patients were monitored from the bicycle ergometry device.
Eligibility Criteria
You may qualify if:
- \- Patients who had isolated CABG surgery 3 months ago, patients with EF 50% and above, patients who are eligible for the CR program, patients who agree to participate in the study, patients who are 18 years of age and above
You may not qualify if:
- Patients who did not consent to participate in the study, patients who had emergency CABG surgery, patients who had minimally invasive CABG surgery, patients who had repeat cardiac surgery, patients with a disease that was not suitable for the CR program (e.g., stage IV heart failure, unstable angina), patients with EF \< 50%, patients with a psychiatric diagnosis and patients using medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
Trabzon, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Professor
Study Record Dates
First Submitted
May 5, 2025
First Posted
May 14, 2025
Study Start
January 1, 2025
Primary Completion
April 29, 2025
Study Completion
April 29, 2025
Last Updated
May 14, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share