Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02224495
Status:
COMPLETED
Last Update Posted:
2014-08-25
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exercise Training on Cardiac Structure and Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)", 'timeFrame': '4 months', 'description': 'Determined by echocardiography; results in cm/s'}], 'secondaryOutcomes': [{'measure': "Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)", 'timeFrame': '4 months', 'description': 'Determined by echocardiography; no unit (ratio)'}, {'measure': "Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)", 'timeFrame': '4 months', 'description': 'Determined by echocardiography; results in cm/s'}, {'measure': 'Left ventriclular ejection fraction', 'timeFrame': '4 months', 'description': 'Determined by echocardiography; results in %'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '25872588', 'type': 'DERIVED', 'citation': 'Fontes-Carvalho R, Sampaio F, Teixeira M, Gama V, Leite-Moreira AF. The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial. Trials. 2015 Mar 12;16:90. doi: 10.1186/s13063-015-0612-6.'}]}, 'descriptionModule': {'briefSummary': 'Exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling.\n\nHowever, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters.\n\nThe hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients one month after myocardial infarction\n* Older 18 years\n\nExclusion Criteria:\n\n* Age above 75 years,\n* Inability to exercise,\n* Hemodinamically significant valvular disease,\n* Moderate to severe chronic lung disease (vital capacity and/or forced expiratory volume in 1 s \\<80% of age-dependent predicted value),\n* Atrial fibrillation\n* Exercise induced myocardial ischemia\n* Anaemia (haemoglobin \\<12 g/dl).'}, 'identificationModule': {'nctId': 'NCT02224495', 'briefTitle': 'The Effect of Exercise Training on Cardiac Structure and Function', 'organization': {'class': 'OTHER', 'fullName': 'Gaia Hospital'}, 'officialTitle': 'The Effect of Exercise Training on Cardiac Structure and Function', 'orgStudyIdInfo': {'id': 'ET2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Standard of care'}, {'type': 'EXPERIMENTAL', 'label': 'Structured exercise training', 'description': '8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training', 'interventionNames': ['Behavioral: Structured exercise training']}], 'interventions': [{'name': 'Structured exercise training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Structured exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4450-189', 'city': 'Gaia', 'country': 'Portugal', 'facility': 'Cardiology Department Gaia Hospital Center', 'geoPoint': {'lat': 40.40674, 'lon': -7.32862}}], 'overallOfficials': [{'name': 'Adelino Leite-Moreira, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaia Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade do Porto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ricardo Fontes Carvalho', 'investigatorAffiliation': 'Gaia Hospital'}}}}