Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-06 @ 9:39 AM
Study NCT ID:
NCT02796404
Status:
UNKNOWN
Last Update Posted:
2016-06-10
First Post:
2016-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homebased Monitoring Cardiac Rehabilitation Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness measured by exercise testing and control of cardiovascular risk factors', 'timeFrame': 'During 12 months', 'description': 'functional capacity obtained by exercise testing and control of cardiovascular risk factors.'}], 'secondaryOutcomes': [{'measure': 'Results of homebased cardiac rehabilitation monitoring a traditional cardiac rehabilitation program', 'timeFrame': 'During 12 months', 'description': 'comparing the results of functional capacity measured by exercise testing and control of cardiovascular risk factors between the two groups'}, {'measure': 'Adherence to these programs', 'timeFrame': '3, 6 and 12 months', 'description': 'see adherence to these program at 3, 6 months and a year depending on the habit of exercise and control of cardiovascular risk factors.'}, {'measure': 'Safety to these program', 'timeFrame': 'During 12 months', 'description': 'See the safety of home cardiac rehabilitation program of mixed surveillance compared to traditional cardiac rehabilitation program to checking the existence of adverse cardiac events.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['home monitoring', 'cardiac monitoring'], 'conditions': ['Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '37593110', 'type': 'DERIVED', 'citation': 'Yang Z, Jia X, Li J, Mei Z, Yang L, Yan C, Han Y. Efficacy and Safety of Hybrid Comprehensive Telerehabilitation (HCTR) for Cardiac Rehabilitation in Patients with Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Occup Ther Int. 2023 Aug 9;2023:5147805. doi: 10.1155/2023/5147805. eCollection 2023.'}, {'pmid': '33580174', 'type': 'DERIVED', 'citation': 'Bravo-Escobar R, Gonzalez-Represas A, Gomez-Gonzalez AM, Heredia-Torres A. Effectiveness of e-Health cardiac rehabilitation program on quality of life associated with symptoms of anxiety and depression in moderate-risk patients. Sci Rep. 2021 Feb 12;11(1):3760. doi: 10.1038/s41598-021-83231-y.'}, {'pmid': '28219338', 'type': 'DERIVED', 'citation': 'Bravo-Escobar R, Gonzalez-Represas A, Gomez-Gonzalez AM, Montiel-Trujillo A, Aguilar-Jimenez R, Carrasco-Ruiz R, Salinas-Sanchez P. Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: A randomised, controlled clinical trial. BMC Cardiovasc Disord. 2017 Feb 20;17(1):66. doi: 10.1186/s12872-017-0499-0.'}]}, 'descriptionModule': {'briefSummary': 'The current state of mobile communication and technology is a tool to support home programs for chronic disease management, useful to facilitate access to these types of programs, because the investigators could obtain telematics information about the parameters, reducing cardiovascular risk factors and cardiovascular morbidity and mortality.', 'detailedDescription': 'The current state of mobile communication and technology is a tool to support home programs for chronic disease management, useful to facilitate access to these types of programs, because the investigators could obtain telematics information about the parameters, reducing cardiovascular risk factors and cardiovascular morbidity and mortality.\n\nOnce the patient qualifies for inclusion in the study and has signed informed consent it is included in a list where randomized 7 patients in the experimental group (home-based cardiac rehabilitation Nuubo monitoring vest) and 7 patients are assigned to traditional cardiac rehabilitation group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll of them:\n\n* Age ≤ 80 years.\n* Stable Ischemic heart disease, revascularized by angioplasty or underwent surgery by coronary bypass \\<= one year from the acute episode.\n* Good cognitive level.\n* Ability to perform aerobic exercise tape or cycle ergometer.\n* Understand the use of a mobile Smartphone or Tablet.\n* Signature of informed consent.\n\nAnd at least one of the following:\n\n* Ventricular dysfunction by Ejection Fraction (FE) 40 - 50%.\n* Functional capacity 5-7 metabolic equivalents (METS).\n* Raising the blood pressure with the effort.\n\nExclusion Criteria:\n\n* Presence of malignant arrhythmias such as ventricular fibrillation outside the acute phase of Acute myocardial infarction (AMI) (\\> 24 h after AMI), ventricular tachycardia, Atrioventricular block of 2nd degree and 3rd degree, Atrial fibrilation (FA) in patients with Wolf Parkinson White, fibrillation or paroxysmal atrial flutter with response ventricular quickly and hemodynamic deterioration, premature ventricular contractions increases during exertion, paroxysmal supraventricular tachycardia uncontrolled.\n* Previous infarcts.\n* Hypotensive response to exercise.\n* Myocardial Ischemia valued at exercise test.\n* Unstable Angina.\n* Nonrevascularizable disease.\n* Poorly controlled hypertension baseline.\n* Killip III and IV Killip.\n* No collaborator.\n* Valvular heart disease associated.\n* Pacemaker or Implantable Cardioverter Defibrillator.\n* Pathology of musculoskeletal, neurological or breathing that impair the ability of prolonged ambulation.'}, 'identificationModule': {'nctId': 'NCT02796404', 'acronym': 'NUUBO', 'briefTitle': 'Homebased Monitoring Cardiac Rehabilitation Program', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}, 'officialTitle': 'Effectiveness of a Homebased Cardiac Rehabilitation Program of Mixed Surveillance Using NUUBO Monitoring Vest in Patients With Ischemic Heart Disease at Moderate Cardiovascular Risk', 'orgStudyIdInfo': {'id': 'NUUBO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homebased cardiac rehabilitation program', 'description': 'Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance.', 'interventionNames': ['Device: Homebased cardiac rehabilitation program', 'Other: Traditional cardiac rehabilitation program']}, {'type': 'OTHER', 'label': 'Traditional cardiac rehabilitation', 'description': 'Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice', 'interventionNames': ['Other: Traditional cardiac rehabilitation program']}], 'interventions': [{'name': 'Homebased cardiac rehabilitation program', 'type': 'DEVICE', 'description': 'homebased cardiac rehabilitation program with monitoring vest Nuubo', 'armGroupLabels': ['Homebased cardiac rehabilitation program']}, {'name': 'Traditional cardiac rehabilitation program', 'type': 'OTHER', 'description': 'multidisciplinary intervention in cardiac rehabilitation gym', 'armGroupLabels': ['Homebased cardiac rehabilitation program', 'Traditional cardiac rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Almería', 'state': 'Almería', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Francisco Chiquero, MD', 'role': 'CONTACT'}, {'name': 'Jose Francisco Chiquero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jose Ramon Vicente, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carlos Gómez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Beatriz Vargas', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cristina Vicario', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ines Maillo', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Mediterráneo', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Córdoba', 'state': 'Córdoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Angela Heredia, MD', 'role': 'CONTACT'}, {'name': 'Angela Heredia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'José López, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pilar Cano, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Milagros Ramos', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Malaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gloria Luque, MD', 'role': 'CONTACT', 'email': 'gloria.luque@fimabis.org', 'phone': '34951291977'}, {'name': 'Adela Gómez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Angel Montiel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rafael Aguilar', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rosa Carrasco', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Raquel Bravo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'centralContacts': [{'name': 'Raquel Bravo, MD', 'role': 'CONTACT', 'email': 'rbravoescobar@yahoo.es', 'phone': '34951291977'}], 'overallOfficials': [{'name': 'Raquel Bravo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'rbravoescobar@yahoo.es'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}