Cardiac RehabilitationNCT06970938
Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery
A study testing Cardiac rehabilitation program in people with Cardiac Rehabilitation and Coronary Artery Bypass Surgery, run by Muhammed Onur Hanedan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Coronary Artery Bypass Surgery
- What is being tested?
- Cardiac rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
Trabzon
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Cardiac rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation programOther
Also called rehabilitation program
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of the effects of cardiac rehabilitation programs on patient outcomes | Experimental | 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. Receives: Other: Cardiac rehabilitation program |
| Comparison of the effects of standard care on patient outcomes | No intervention | The 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: ıt ranges 3 months to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jan 2025
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammed Onur Hanedan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Onur HANEDAN, Muhammed Onur Hanedan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970938
- Sponsor's protocol ID
- 23/12/2024-2024/156
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06970938
- Acronym / sponsor ID
- 23/12/2024-2024/156
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Muhammed Onur HanedanUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison of the effects of cardiac rehabilitation programs on patient outcomes | Experimental | Other: Cardiac rehabilitation programThe 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 intervention | –The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitation programAlso: rehabilitation programThe 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 | Comparison of the effects of cardiac rehabilitation programs on patient outcomes |
Primary outcome
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation program in people with Cardiac Rehabilitation and Coronary Artery Bypass Surgery, run by Muhammed Onur Hanedan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of quality of life of groups (time frame: ıt ranges from 3 months to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.