Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-12 @ 4:28 PM
Study NCT ID:
NCT03926312
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2019-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2019-04-21', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional capacity change', 'timeFrame': '3 months', 'description': '6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention'}], 'secondaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': '3 months', 'description': 'Waist circumference change after 3 months of the intervention'}, {'measure': 'Body fat percentage', 'timeFrame': '3 months', 'description': 'Body fat percentage change after 3 months of the intervention'}, {'measure': 'Smoking cessation', 'timeFrame': '3 months', 'description': 'Smoking cessation after 3 months of the intervention'}, {'measure': 'Lipid levels', 'timeFrame': '3 months', 'description': 'Lipid levels change after 3 months of the intervention'}, {'measure': 'Blood pressure', 'timeFrame': '3 months', 'description': 'Blood pressure change after 3 months of the intervention'}, {'measure': 'Glycated hemoglobin', 'timeFrame': '3 months', 'description': 'Glycated hemoglobin change after 3 months of the intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myocardial infarction', 'cardiac rehabilitation', 'smart device', 'remote monitoring', 'telemonitoring', 'low physical activity', 'risk factors control'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '40206122', 'type': 'DERIVED', 'citation': 'Wohlfahrt P, Jenca D, Melenovsky V, Mrazkova J, Sramko M, Kotrc M, Zelizko M, Adamkova V, Lopez-Jimenez F, Pitha J, Kautzner J. Remote, Smart Device-Based Cardiac Rehabilitation After Myocardial Infarction: A Pilot, Randomized Cross-Over SmartRehab Study. Mayo Clin Proc Digit Health. 2024 Jun 20;2(3):352-360. doi: 10.1016/j.mcpdig.2024.06.001. eCollection 2024 Sep.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the influence of cardiac rehabilitation based on smart band use and telemonitoring on functional capacity change and risk factors control among patients hospitalized for acute myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent with the study\n2. Men and women \\>18 years of age\n3. Patients ≥1 and ≤6 months after type I myocardial infarction\n4. Physical inactivity before MI defined as the absence of moderate to vigorous exercise for at least 30 minutes 5 or more days a week\n\nExclusion Criteria:\n\n1. Heart failure NYHA IIIB-IV\n2. Planned coronary revascularization\n3. Planned major surgery within the next 12 months\n4. Inability to walk for any reason\n5. Comorbidities that would preclude adherence to the rehabilitation program (e.g. arthrosis, active malignancy, major depression or other significant psychiatric disorder, cognitive impairment) - at the discretion of the physician\n6. Life expectancy less than 12 months\n7. Pregnancy\n8. Inability to operate the smart-watch'}, 'identificationModule': {'nctId': 'NCT03926312', 'acronym': 'SmartRehab', 'briefTitle': 'Smart Device-based Cardiac Rehabilitation After Myocardial Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Smart Device-based Cardiac Rehabilitation After Myocardial Intervention', 'orgStudyIdInfo': {'id': 'SmartRehab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart device-based rehabilitation', 'description': 'One month after myocardial infarction, patients will receive a smart band and a cellphone in order to transmit data on physical activity to electronic health record. A study nurse will periodically check compliance with recommended physical activity and intervene in the case of non-compliance.', 'interventionNames': ['Device: Smart device-based cardiac rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients will receive a guideline directed recommendation to increase physical activity to 30 minutes of moderate physical activity a week.'}], 'interventions': [{'name': 'Smart device-based cardiac rehabilitation', 'type': 'DEVICE', 'description': 'A smart device coupled with remote monitoring will be used to increase physical activity of patients after myocardial infarction with a history of low physical activity.', 'armGroupLabels': ['Smart device-based rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14021', 'city': 'Prague', 'state': 'CZEC', 'country': 'Czechia', 'facility': 'Institute for Clinical and Experimental Medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Peter Wohlfahrt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Clinical and Experimental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Wohlfahrt', 'investigatorAffiliation': 'Institute for Clinical and Experimental Medicine'}}}}