Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04000893
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2019-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial function', 'timeFrame': 'Pre and post 5 minutes exercise session', 'description': 'Flow-mediated dilatation technique'}], 'secondaryOutcomes': [{'measure': 'Arterial stiffness', 'timeFrame': 'Pre and post 5 minutes exercise session', 'description': 'Pulse wave velocity technique'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Rehabilitation', 'Aerobic Exercise', 'Resistance Exercise']}, 'referencesModule': {'references': [{'pmid': '33596832', 'type': 'DERIVED', 'citation': 'Kollet DP, Marenco AB, Belle NL, Barbosa E, Boll L, Eibel B, Waclawovsky G, Lehnen AM. Aerobic exercise, but not isometric handgrip exercise, improves endothelial function and arterial stiffness in patients with myocardial infarction undergoing coronary intervention: a randomized pilot study. BMC Cardiovasc Disord. 2021 Feb 17;21(1):101. doi: 10.1186/s12872-021-01849-2.'}]}, 'descriptionModule': {'briefSummary': "Cardiac Rehabilitation, as art and acting science multiprofessional, is based on the training with exercises that provides the post-infarct patients to satisfactorily re-establish the patient's clinical condition and that improve the functional capacity of these individuals.\n\nEvidence shows that aerobic exercise training provides improvements in the endothelial function of this population. However, we do not yet have strong evidence of other modalities of exercise in these parameters in post-infarction patients treated with angioplasty."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Post-acute myocardial infarction patients\n* Ergometric test 30 days after the infarction\n* Ejection fraction\\> 40% (Simpson's method)\n* Regular use of optimized drugs\n\nExclusion Criteria:\n\n* Unable to perform the randomized exercise"}, 'identificationModule': {'nctId': 'NCT04000893', 'briefTitle': 'Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AMI and exercise'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance exercise session', 'description': 'Acute isometric session, about 20 minutes.', 'interventionNames': ['Other: Resistance exercise session']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic exercise session', 'description': 'Acute aerobic session, about 20 minutes.', 'interventionNames': ['Other: Resistance exercise session']}], 'interventions': [{'name': 'Resistance exercise session', 'type': 'OTHER', 'otherNames': ['Aerobic exercise session'], 'description': 'Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.', 'armGroupLabels': ['Aerobic exercise session', 'Resistance exercise session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90620-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Alexandre Lehnen', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Alexandre Lehnen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Cardiologia do Rio Grande do Sul'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}