Coronary Artery BypassNCT07470034
Effects of Diaphragm Release Technique on Sleep Quality and Respiratory Function in Coronary Artery Bypass Graft Patients
A study testing Intervention Group in people with Coronary Artery Bypass and Cardiac Rehabilitation, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of diaphragm relaxation technique on sleep quality and respiratory functions in patients who have undergone coronary artery bypass graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Bypass, Cardiac Rehabilitation
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2025to 15 Feb 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age under 65 years
- Undergoing minimally invasive coronary artery bypass graft (CABG) surgery
- Hemodynamically stable
- Ambulatory (able to walk)
- Willing to participate in the study and provide written informed consent
- Mini-Mental State Examination (MMSE) score ≥ 25
Who cannot join
- History of cerebrovascular events (stroke, TIA)
- Orthopedic problems preventing walking
- Uncontrolled diabetes
- Uncontrolled hypertension
- Severe visual impairment
- Other diseases limiting participation in exercise training (pulmonary, neurological, metabolic, etc.)
- Verbal or auditory cooperation problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Diaphragm Release Technique on Sleep Quality and Respiratory Functions in Patients Undergoing Coronary Artery Bypass Graft Surgery
This study aims to investigate the effects of diaphragm relaxation technique on sleep quality and respiratory functions in patients who have undergone coronary artery bypass graft (CABG) surgery. Two groups will be formed in the study: one group will receive standard cardiac rehabilitation, while the other group will receive diaphragm relaxation technique in addition to this.
Throughout the study, patients' respiratory functions, sleep quality, respiratory muscle strength, and pain levels will be measured. These measurements will be taken from the patients...
Read the detailed description
This study is an interventional research investigating the effects of the diaphragm release technique on sleep quality and respiratory functions in patients undergoing minimally invasive coronary artery bypass graft (CABG) surgery. Participants will be assigned to either an intervention or a control group. Both groups will receive standard in-hospital cardiac rehabilitation, while the intervention group will additionally receive the diaphragm release technique during their hospital stay.
Data will be collected using standardized tools, including pulmonary function tests (spirometry), respiratory muscle strength measurements, the Pittsburgh Sleep Quality Index, and visual analog scales for pain assessment. Written informed consent will be obtained from all participants, and the study will be conducted at Gaziantep Sanko University Hospital Cardiovascular Surgery Unit in accordance with ethical committee approval.
The aim of this research is to develop a safe and effective method to improve respiratory health and quality of life in patients after cardiac surgery.
- Conditions
- Coronary Artery Bypass, Cardiac Rehabilitation
- Being tested
- Intervention Group, Control Group
- Keywords
- Cardiac Rehabilitation, Coronary Artery Bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Participants receive standard in-hospital cardiac rehabilitation plus diaphragm release technique. The diaphragm release is performed daily during the hospital stay for a minimum o
Control GroupOther
Participants receive standard in-hospital cardiac rehabilitation only, including breathing exercises, mobilization, and post-operative physiotherapy, without diaphragm release.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm Release plus Standard Cardiac Rehabilitation | Active comparator | Standard in-hospital cardiac rehabilitation plus diaphragm release technique applied for a minimum of 5 days during hospitalization. Receives: Other: Intervention Group |
| Standard In-Hospital Cardiac Rehabilitation | Active comparator | Standard in-hospital cardiac rehabilitation only. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function (Spirometry)
FEV1/FVC ratio measured with a spirometer. Measurements are performed according to ATS/ERS guidelines.
Measured: 1 years
Sleep Quality (Pittsburgh Sleep Quality Index)
sleep latency and daytime dysfunction evaluated using the Pittsburgh Sleep Quality Index.
Measured: 1 years
Respiratory Muscle Strength (MIP/MEP)
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured using an oral pressure device to evaluate respiratory muscle strength.
Measured: 1 years
Pain Level (Visual Analog Scale)
Chest and incision site pain assessed using a 0-10 cm Visual Analog Scale (0 = no pain, 10 = worst pain imaginable). Measured during rest, activity, and night.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start30 Aug 2025
- Primary completion15 Jan 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies 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
- Model description
- This is a two-arm interventional study designed to evaluate the effects of the diaphragm release technique on post-operative respiratory function and sleep quality in patients undergoing minimally invasive coronary artery bypass graft (CABG) surgery. Participants will be assigned to either: Intervention Group: Receives standard in-hospital cardiac rehabilitation plus diaphragm release technique during hospitalization (minimum 5 days). Control Group: Receives standard in-hospital cardiac rehabilitation only. The study follows a prospective, controlled design, with all interventions delivered according to a standardized protocol. Outcomes, including pulmonary function tests, respiratory muscle strength, sleep quality, and pain scores, will be measured at baseline and throughout the hospital stay. Data will be analyzed to compare the physiological and clinical effects between the two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Bağcı, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470034
- Sponsor's protocol ID
- burcubagci6
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragm Release Technique on Sleep Quality and Respiratory Functions in Patients Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07470034
- Acronym / sponsor ID
- burcubagci6
- Conditions
- Coronary Artery Bypass, Cardiac Rehabilitation
- Keywords
- Cardiac Rehabilitation, Coronary Artery Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 13 Mar 2026 (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 aims to investigate the effects of diaphragm relaxation technique on sleep quality and respiratory functions in patients who have undergone coronary artery bypass graft (CABG) surgery. Two groups will be formed in the study: one group will receive standard cardiac rehabilitation, while the other group will receive diaphragm relaxation technique in addition to this.
Throughout the study, patients' respiratory functions, sleep quality, respiratory muscle strength, and pain levels will be measured. These measurements will be taken from the patients...
Detailed description
This study is an interventional research investigating the effects of the diaphragm release technique on sleep quality and respiratory functions in patients undergoing minimally invasive coronary artery bypass graft (CABG) surgery. Participants will be assigned to either an intervention or a control group. Both groups will receive standard in-hospital cardiac rehabilitation, while the intervention group will additionally receive the diaphragm release technique during their hospital stay.
Data will be collected using standardized tools, including pulmonary function tests (spirometry), respiratory muscle strength measurements, the Pittsburgh Sleep Quality Index, and visual analog scales for pain assessment. Written informed consent will be obtained from all participants, and the study will be conducted at Gaziantep Sanko University Hospital Cardiovascular Surgery Unit in accordance with ethical committee approval.
The aim of this research is to develop a safe and effective method to improve respiratory health and quality of life in patients after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-arm interventional study designed to evaluate the effects of the diaphragm release technique on post-operative respiratory function and sleep quality in patients undergoing minimally invasive coronary artery bypass graft (CABG) surgery. Participants will be assigned to either: Intervention Group: Receives standard in-hospital cardiac rehabilitation plus diaphragm release technique during hospitalization (minimum 5 days). Control Group: Receives standard in-hospital cardiac rehabilitation only. The study follows a prospective, controlled design, with all interventions delivered according to a standardized protocol. Outcomes, including pulmonary function tests, respiratory muscle strength, sleep quality, and pain scores, will be measured at baseline and throughout the hospital stay. Data will be analyzed to compare the physiological and clinical effects between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Diaphragm Release plus Standard Cardiac Rehabilitation | Active comparator | Other: Intervention GroupStandard in-hospital cardiac rehabilitation plus diaphragm release technique applied for a minimum of 5 days during hospitalization. |
| Standard In-Hospital Cardiac Rehabilitation | Active comparator | Other: Control GroupStandard in-hospital cardiac rehabilitation only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age under 65 years
- Undergoing minimally invasive coronary artery bypass graft (CABG) surgery
- Hemodynamically stable
- Ambulatory (able to walk)
- Willing to participate in the study and provide written informed consent
Key exclusion criteria (7 listed)
- History of cerebrovascular events (stroke, TIA)
- Orthopedic problems preventing walking
- Uncontrolled diabetes
- Uncontrolled hypertension
- Severe visual impairment
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 |
|---|---|---|
| Intervention GroupParticipants receive standard in-hospital cardiac rehabilitation plus diaphragm release technique. The diaphragm release is performed daily during the hospital stay for a minimum o | Other | Diaphragm Release plus Standard Cardiac Rehabilitation |
| Control GroupParticipants receive standard in-hospital cardiac rehabilitation only, including breathing exercises, mobilization, and post-operative physiotherapy, without diaphragm release. | Other | Standard In-Hospital Cardiac Rehabilitation |
Primary outcome
Pulmonary Function (Spirometry)
Time frame: 1 years
FEV1/FVC ratio measured with a spirometer. Measurements are performed according to ATS/ERS guidelines.
Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: 1 years
sleep latency and daytime dysfunction evaluated using the Pittsburgh Sleep Quality Index.
Respiratory Muscle Strength (MIP/MEP)
Time frame: 1 years
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured using an oral pressure device to evaluate respiratory muscle strength.
Pain Level (Visual Analog Scale)
Time frame: 1 years
Chest and incision site pain assessed using a 0-10 cm Visual Analog Scale (0 = no pain, 10 = worst pain imaginable). Measured during rest, activity, and night.
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 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Coronary Artery Bypass Graft (CABG)
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 Intervention Group in people with Coronary Artery Bypass and Cardiac Rehabilitation, run by Sanko University 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 6 inclusion and 7 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 13 Mar 2026. 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?
Pulmonary Function (Spirometry) (time frame: 1 years). 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 13 Mar 2026.