Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 6:30 PM
Study NCT ID:
NCT07470034
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Diaphragm Release Technique on Sleep Quality and Respiratory Function in Coronary Artery Bypass Graft Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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:\n\nIntervention Group: Receives standard in-hospital cardiac rehabilitation plus diaphragm release technique during hospitalization (minimum 5 days).\n\nControl 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Function (Spirometry)', 'timeFrame': '1 years', 'description': 'FEV1/FVC ratio measured with a spirometer. Measurements are performed according to ATS/ERS guidelines.'}, {'measure': 'Sleep Quality (Pittsburgh Sleep Quality Index)', 'timeFrame': '1 years', 'description': 'sleep latency and daytime dysfunction evaluated using the Pittsburgh Sleep Quality Index.'}, {'measure': 'Respiratory Muscle Strength (MIP/MEP)', 'timeFrame': '1 years', 'description': 'Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured using an oral pressure device to evaluate respiratory muscle strength.'}, {'measure': 'Pain Level (Visual Analog Scale)', 'timeFrame': '1 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Rehabilitation', 'Coronary Artery Bypass'], 'conditions': ['Coronary Artery Bypass', 'Cardiac Rehabilitation']}, 'descriptionModule': {'briefSummary': "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.\n\nThroughout the study, patients' respiratory functions, sleep quality, respiratory muscle strength, and pain levels will be measured. These measurements will be taken from the patients...", 'detailedDescription': '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.\n\nData 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age under 65 years\n* Undergoing minimally invasive coronary artery bypass graft (CABG) surgery\n* Hemodynamically stable\n* Ambulatory (able to walk)\n* Willing to participate in the study and provide written informed consent\n* Mini-Mental State Examination (MMSE) score ≥ 25\n\nExclusion Criteria:\n\n* History of cerebrovascular events (stroke, TIA)\n* Orthopedic problems preventing walking\n* Uncontrolled diabetes\n* Uncontrolled hypertension\n* Severe visual impairment\n* Other diseases limiting participation in exercise training (pulmonary, neurological, metabolic, etc.)\n* Verbal or auditory cooperation problems'}, 'identificationModule': {'nctId': 'NCT07470034', 'briefTitle': 'Effects of Diaphragm Release Technique on Sleep Quality and Respiratory Function in Coronary Artery Bypass Graft Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sanko University'}, 'officialTitle': 'Effects of Diaphragm Release Technique on Sleep Quality and Respiratory Functions in Patients Undergoing Coronary Artery Bypass Graft Surgery', 'orgStudyIdInfo': {'id': 'burcubagci6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diaphragm Release plus Standard Cardiac Rehabilitation', 'description': 'Standard in-hospital cardiac rehabilitation plus diaphragm release technique applied for a minimum of 5 days during hospitalization.', 'interventionNames': ['Other: Intervention Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard In-Hospital Cardiac Rehabilitation', 'description': 'Standard in-hospital cardiac rehabilitation only.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Intervention Group', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Diaphragm Release plus Standard Cardiac Rehabilitation']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Participants receive standard in-hospital cardiac rehabilitation only, including breathing exercises, mobilization, and post-operative physiotherapy, without diaphragm release.', 'armGroupLabels': ['Standard In-Hospital Cardiac Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27500', 'city': 'Gaziantep', 'state': 'şehitkamil', 'country': 'Turkey (Türkiye)', 'facility': 'Sanko Unıversıty', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanko University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ass prof', 'investigatorFullName': 'Burcu Bağcı', 'investigatorAffiliation': 'Sanko University'}}}}