Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-29 @ 11:58 PM
Study NCT ID:
NCT04048057
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2019-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Exercise Programs in Coronary Artery Patients: A Randomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-18', 'studyFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise capacity', 'timeFrame': '15 minutes', 'description': 'Cardiopulmonary exercise test'}], 'secondaryOutcomes': [{'measure': 'MacNew Health Related Quallity of Life Qustionnaire', 'timeFrame': '15 minutes', 'description': 'The validity and reliability of the MacNew Heart Disease Health-Related Quality of Life Questionnaire Daşkapan et al. in 2008. It is a scale developed to determine the quality of life in heart diseases consisting of 27 items each containing a 7-point Likert type response. In the evaluation of the scale, 3 sub-dimensions (emotional, physical and social) and total score values are used'}, {'measure': 'body composition', 'timeFrame': '1 minute', 'description': 'Tanita'}, {'measure': 'physical activity level', 'timeFrame': '15 minutes', 'description': 'International Physical Activity Questionnaire'}, {'measure': 'fear of movement', 'timeFrame': '15 minutes', 'description': 'Tampa'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise', 'Cardiac Rehabilitation']}, 'descriptionModule': {'briefSummary': 'There are studies showing the superiority of HIIT protocols in patients with CAD in the literature, however there is no consensus on the use of HIIT protocols in CAD patients. In addition, in these studies, the HIIT protocols differ in severity and duration and there is no optimal HIIT protocol. Therefore, this study was planed to investigate of two different HIIT protocols and one MICT protocols, which are more commonly used in patients with CAD in the literature on exercise capacity, quality of life, body composition, physical activity level and fear of movement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have undergone percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery,\n* Nonobstructive CAD registered by angiography\n* Left ventricular ejection fraction above 50%,\n* Clinically stable for more than 2 weeks in terms of symptoms and medical treatment.\n\nExclusion Criteria:\n\n* Ischemia symptoms,\n* Being in Class III-IV according to the New York Heart Classification,\n* Obtaining significant left ventricular outflow obstruction,\n* Ventricular arrhythmia,\n* Being marked valvular heart disease,\n* Failure to comply with exercise testing and training rules,\n* To have significant orthopedic or neurological comorbidity that prevents full participation.'}, 'identificationModule': {'nctId': 'NCT04048057', 'briefTitle': 'The Effect of Different Exercise Programs in Coronary Artery Patients: A Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'The Effect of Different Exercise Programs in Coronary Artery Patients: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'KMSU-Exercise'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modarete Intensity Continous Training', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'High Intensity Interval Training I', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'High Intensity Interval Training II', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Modarete Intensity Continous Training: Medium intensity continuous exercise training will be performed. Exercise intensity will be adjusted as 50-70% of maximal power.\n\nHigh Intensity Interval Training I: It will be four cycles consisting of 4 minute high intensity exercise phase and 3 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power.\n\nHigh Intensity Interval Training II: It will be 10 cycles consisting of 1 minute high intensity exercise phase and 1 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power.', 'armGroupLabels': ['High Intensity Interval Training I', 'High Intensity Interval Training II', 'Modarete Intensity Continous Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43100', 'city': 'Kütahya', 'state': 'Center', 'country': 'Turkey (Türkiye)', 'facility': 'Kutahya Health Sciences University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kutahya Medical Sciences University', 'investigatorFullName': 'Ismail Okur', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}