Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-04 @ 12:04 AM
Study NCT ID:
NCT03208751
Status:
UNKNOWN
Last Update Posted:
2019-07-19
First Post:
2017-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single-arm intervention with exercise training as secondary prevention strategy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2017-05-26', 'studyFirstSubmitQcDate': '2017-07-02', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in VO2peak in ml/kg/min', 'timeFrame': '6 months', 'description': 'Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c for patients with diabetes', 'timeFrame': '6 months', 'description': 'Glycated hemoglobin \\>5,7 corresponds to glucose intolerance, \\> 6,5 is diagnosed diabetes mellitus'}, {'measure': 'Change in hsCRP', 'timeFrame': '6 months', 'description': 'high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events'}, {'measure': "Change in E/e'", 'timeFrame': '6 months', 'description': "E/e' is an echocardiographic marker for diastolic function, an E/e' \\< 8 is considered as normal"}, {'measure': 'Change in quality of life measured by SF-36', 'timeFrame': '6 months', 'description': 'The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured'}, {'measure': 'Change in insulin IU', 'timeFrame': '6 months', 'description': 'Insulin dosage is measured in IE (international units)'}, {'measure': 'Change in HDL- and LDL- cholesterol as well as triglycerides', 'timeFrame': '6 months', 'description': 'all measured in mg/dl'}, {'measure': 'Change in Adiponectin', 'timeFrame': '6 months', 'description': 'Adiponectin is an adipokine which is released by fat tissue'}, {'measure': 'Change in Watts at anaerobic threshold VAT', 'timeFrame': '6 months', 'description': 'VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing'}, {'measure': 'Change in Watts at anaerobic threshold RCP', 'timeFrame': '6 months', 'description': 'RCP= respiratory compensation point, measured by cardiopulmonary exercise testing'}, {'measure': 'Change in max. Watts', 'timeFrame': '6 months', 'description': 'On bicycle ergometry, Watts are measured'}, {'measure': 'Change in max. Watts/kg bodyweight', 'timeFrame': '6 months', 'description': 'max. Watts indexed b body weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Training', 'Coronary Artery Disease', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. The objective of this study is to translate regular exercise training into a community based setting. A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.', 'detailedDescription': 'From 2011, patients insured at "Techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program. Training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training. The last phase of 12 weeks, supervised training is only once/week. Patients are asked to perform exercise training 3-5 times weekly. At the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn. Training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks. Resistance training starts after 6 weeks and is performed within the supervised training. All patients were offered an individual nutritional counseling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery disease and/or diabetes mellitus\n* Heart failure\n\nExclusion Criteria:\n\n* all conditions which are not compatible with exercise training:\n* severe orthopedic disorders\n* severe psychiatric disease\n* severe valve insufficiency\n* presence of myocardial ischemia (decision made by cardiologist)'}, 'identificationModule': {'nctId': 'NCT03208751', 'briefTitle': 'Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting', 'orgStudyIdInfo': {'id': '5132/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercise training', 'description': 'All patients were included in the exercise training group', 'interventionNames': ['Behavioral: Exercise training']}], 'interventions': [{'name': 'Exercise training', 'type': 'BEHAVIORAL', 'description': 'Exercise intervention was divided into 3 phases:\n\nPhase 1: 6 weeks of moderate continuous training (MCT) 20 to 40 minutes at intensity of 60% of VO2peak, 3 times/week Phase 2: 6 weeks of moderate intensity interval training (MIIT) 30-40 min, intensity 60 to 80% of VO2peak, twice weekly plus at least once weekly MCT home based training Phase 3 (after performing new exercise testing to adapt training intensities): 12 weeks of MIIT 40 min once/week, intensity 60-80/85% of VO2peak, plus at least twice weekly home based MCT. From phase 2, supervised sessions included resistance training of at least 3 muscle groups, 3x15 repetitions at moderate intensity (Borg 12-14).\n\nNutritional counseling is offered up to 4 times in 6 months on an individual basis.', 'armGroupLabels': ['Exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar/ Technische Universitaet Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Martin Halle, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Technical University Munic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jeffrey W Christle', 'investigatorAffiliation': 'Technical University of Munich'}}}}