Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-11 @ 12:04 AM
Study NCT ID:
NCT03821558
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2019-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training in Individuals With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'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': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2019-01-06', 'studyFirstSubmitQcDate': '2019-01-27', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in the flow-mediated dilation during single exercise training session, measured in %', 'timeFrame': '3 months'}, {'measure': 'Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels during single exercise training session, measured in ng/l', 'timeFrame': '3 months'}, {'measure': 'Change in selectin and hsCRP during single exercise training session, measured in mg/l', 'timeFrame': '3 months'}, {'measure': 'Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF levels during single exercise training session, measured in ng/l', 'timeFrame': '3 months'}, {'measure': 'Change in copeptin levels during single exercise training session, measured in pmol/l', 'timeFrame': '3 months'}, {'measure': 'Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l', 'timeFrame': '3 months'}, {'measure': 'Change in fibrinogen level during single exercise training session, measured in mg/dl', 'timeFrame': '3 months'}, {'measure': 'Change in insuline levels during single exercise training session, measure in microIU/ml', 'timeFrame': '3 months'}, {'measure': 'Change in osteopontin and D-dimer levels during single exercise training session, measured in microg/l', 'timeFrame': '3 months'}, {'measure': 'Change in overall haemostatic potential during single exercise training session', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'Change of flow-mediated dilatation of the brachial artery, measured in %', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Change of the arterial stiffness coefficient', 'timeFrame': '3 months'}, {'measure': 'Change of maximal oxygen uptake during exercise, measured in ml/kg/min', 'timeFrame': '3 months'}, {'measure': 'Change of the heart rate variability', 'timeFrame': '3 months'}, {'measure': 'Change of the heart rate recovery', 'timeFrame': '3 months'}, {'measure': 'Change in health-related quality of life using SF-36 questionnaire, measured in points', 'timeFrame': '3 months', 'description': 'It is a self-administered questionnaire comprising 36 items measuring eight dimensions and two subscales (physical and mental)'}, {'measure': 'Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l', 'timeFrame': '3 months'}, {'measure': 'Change in osteopontin and D-dimer levels, measured in microg/l', 'timeFrame': '3 months'}, {'measure': 'Change in selectin and hsCRP, measured in mg/l', 'timeFrame': '3 months'}, {'measure': 'Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l', 'timeFrame': '3 months'}, {'measure': 'Change in copeptin levels, measured in pmol/l', 'timeFrame': '3 months'}, {'measure': 'Change in MR-proADM and MR-proANP, measured in nmol/l', 'timeFrame': '3 months'}, {'measure': 'Change in homoarginine, ADMA and SDMA levels, measured in micromol/l', 'timeFrame': '3 months'}, {'measure': 'Change in fibrinogen and Lp(a) levels, measured in mg/dl', 'timeFrame': '3 months'}, {'measure': 'Change in insuline level, measure in microIU/ml', 'timeFrame': '3 months'}, {'measure': 'Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l', 'timeFrame': '3 months'}, {'measure': 'Change in overall haemostatic potential', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'interval training', 'continuous training', 'endothelial dysfunction'], 'conditions': ['Coronary Artery Disease', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '17548726', 'type': 'BACKGROUND', 'citation': 'Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.'}, {'pmid': '26375499', 'type': 'BACKGROUND', 'citation': 'Liou K, Ho S, Fildes J, Ooi SY. High Intensity Interval versus Moderate Intensity Continuous Training in Patients with Coronary Artery Disease: A Meta-analysis of Physiological and Clinical Parameters. Heart Lung Circ. 2016 Feb;25(2):166-74. doi: 10.1016/j.hlc.2015.06.828. Epub 2015 Jul 22.'}, {'pmid': '25464446', 'type': 'BACKGROUND', 'citation': 'Conraads VM, Pattyn N, De Maeyer C, Beckers PJ, Coeckelberghs E, Cornelissen VA, Denollet J, Frederix G, Goetschalckx K, Hoymans VY, Possemiers N, Schepers D, Shivalkar B, Voigt JU, Van Craenenbroeck EM, Vanhees L. Aerobic interval training and continuous training equally improve aerobic exercise capacity in patients with coronary artery disease: the SAINTEX-CAD study. Int J Cardiol. 2015 Jan 20;179:203-10. doi: 10.1016/j.ijcard.2014.10.155. Epub 2014 Oct 25.'}, {'pmid': '28648356', 'type': 'BACKGROUND', 'citation': 'Villelabeitia-Jaureguizar K, Vicente-Campos D, Senen AB, Jimenez VH, Garrido-Lestache MEB, Chicharro JL. Effects of high-intensity interval versus continuous exercise training on post-exercise heart rate recovery in coronary heart-disease patients. Int J Cardiol. 2017 Oct 1;244:17-23. doi: 10.1016/j.ijcard.2017.06.067. Epub 2017 Jun 17.'}, {'pmid': '23724882', 'type': 'BACKGROUND', 'citation': 'Currie KD, Rosen LM, Millar PJ, McKelvie RS, MacDonald MJ. Heart rate recovery and heart rate variability are unchanged in patients with coronary artery disease following 12 weeks of high-intensity interval and moderate-intensity endurance exercise training. Appl Physiol Nutr Metab. 2013 Jun;38(6):644-50. doi: 10.1139/apnm-2012-0354. Epub 2013 Jan 17.'}, {'pmid': '29338917', 'type': 'BACKGROUND', 'citation': 'Novakovic M, Prokselj K, Rajkovic U, Vizintin Cuderman T, Jansa Trontelj K, Fras Z, Jug B. Exercise training in adults with repaired tetralogy of Fallot: A randomized controlled pilot study of continuous versus interval training. Int J Cardiol. 2018 Mar 15;255:37-44. doi: 10.1016/j.ijcard.2017.12.105. Epub 2018 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'In this controlled trial, patients referred to post-myocardial infarction cardiac rehabilitation will be randomized to either interval or continuous training.', 'detailedDescription': 'The trial would i) compare the acute effects of each exercise type on selected cardiovascular indicators; ii) compare the chronic effects of each exercise type on selected cardiovascular indicators; iii) provide information on the association between acute and chronic effects of each exercise type; iv) provide insight into possible mechanisms of effectiveness of each exercise type; v) identify the most safe and effective exercise type for patients with coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* myocardium infarction 120 days prior to cardiac rehabilitation\n\nExclusion Criteria:\n\n* contraindications for exercise training,\n* uncontrolled dysrhythmias,\n* uncontrolled heart failure (New York Heart Association (NYHA) stage IV),\n* intellectual development disorder,\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT03821558', 'acronym': 'ReKoBo', 'briefTitle': 'Exercise Training in Individuals With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters', 'orgStudyIdInfo': {'id': 'UKCLRehab0012019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interval training group', 'description': "Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak exercise performance) and low-intensity intervals (60-70% of peak exercise performance).", 'interventionNames': ['Other: Exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous training group', 'description': "Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo moderate continuous exercise training at 75% of peak exercise performance.", 'interventionNames': ['Other: Exercise training']}], 'interventions': [{'name': 'Exercise training', 'type': 'OTHER', 'description': "Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.", 'armGroupLabels': ['Continuous training group', 'Interval training group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Borut Jug, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Ljubljana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Borut Jug', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}