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Completed

NCT Number: NCT06970938

Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery

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.

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Key information

Conditions

Cardiac Rehabilitation Coronary Artery Bypass Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

Trabzon, Turkey (Türkiye)

About this study

Hypothesis 1:

H0: Cardiac rehabilitation has no effect on quality of life patients with CABG surgery.

H1: Cardiac rehabilitation has an effect on quality of life patients with CABG surgery.

Hypothesis 2:

H0: Cardiac rehabilitation has no effect on sleep quality patients with CABG surgery.

H1: Cardiac rehabilitation has an effect on sleep quality patients with CABG surgery.

Hypothesis 3:

H0: Cardiac rehabilitation has no effect on anxiety and depression patients with CABG surgery.

H1: Cardiac rehabilitation has an effect on anxiety and depression with CABG surgery.

H0: Cardiac rehabilitation has no effect on cardiopulmonary function patients with CABG surgery.

H1: Cardiac rehabilitation has an effect on cardiopulmonary function patients with CABG surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cardiac rehabilitation program

Other

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.

Other names: rehabilitation program

Primary outcomes

  1. Evaluation of quality of life of groups

    Time frame: ıt ranges from 3 months to 6 months

    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.

  2. Evaluation of sleep quality of groups

    Time frame: ıt ranges 3 months to 6 months

    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.

  3. Evaluation of depression and anxiety of groups

    Time frame: ıt ranges 3 months to 6 months

    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.

  4. Evaluation of cardiopulmonary functions of groups

    Time frame: ıt ranges 3 months to 6 months

    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

Sponsors and collaborators

Lead sponsor

Muhammed Onur Hanedan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

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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