Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-26 @ 11:16 PM
Study NCT ID:
NCT04121702
Status:
UNKNOWN
Last Update Posted:
2019-10-11
First Post:
2019-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to physical exercise', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Adherence to physical exercise measured by number of physical exercise sessions realized by each patient'}, {'measure': 'Functional capacity', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Change of functional capacity measured by cardiopulmonary exercise test'}], 'secondaryOutcomes': [{'measure': 'Glucose levels', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on the glucose metabolic profile (mg/dL)'}, {'measure': 'Glycated hemoglobin levels (HbA1c)', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on the glycated hemoglobin (mg/dL)'}, {'measure': 'Low-density lipoprotein (LDL) levels', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on the LDL metabolic profile (mg/dL)'}, {'measure': 'High-density lipoprotein (HDL) levels', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on the HDL metabolic profile (mg/dL)'}, {'measure': 'Total colesterol levels', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on the total colesterol metabolic profile (mg/dL)'}, {'measure': 'Blood pressure levels', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on systolic and diastolic blood pressure levels (mmHg)'}, {'measure': 'Smoking', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on smoking status (cessation of smoking)'}, {'measure': 'Weight', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on weight (kg)'}, {'measure': 'Abdominal perimeter', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on abdominal perimeter (cm)'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on body mass index (weight in kg and height in meters will be combined to calculate BMI in kg/m˄2)'}, {'measure': 'Adherence to Mediterranean Diet', 'timeFrame': 'At the end of the program (6 weeks)', 'description': 'Evaluate changes on mediterranean dietary habits measured ussing the Mediterranean Diet Assessment Scale (MEDAS) which is constituted by 14 ítems with questions concerning dietary habits related to the medditerranean dietary style. Minimum score: 0, maximum score: 14. Values over 9 are corresponded to good adherence to mediterranean diet, values under 9 are considered to be bad adherence.'}, {'measure': 'Phisical exercise profile', 'timeFrame': 'At the end of the program (6 weeks)', 'description': "Evaluate changes on level of physical activity measured ussing the International Physical Activity Questionnaire (IPAQ). It asks about three specific types of activity undertaken in the four domains: leisure time physical activity, domestic and gardening (yard) activities, work-related physical activity, transport-related physical activity. The specific types of activity that are assessed are walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.\n\nMaximun value: the sum total of all Walking, Moderate and Vigorous time variables greater than 960 minutes (16 hours).\n\nMínimum value: Only values of 10 or more minutes of activity should be included in the calculation of summary scores. Responses of less than 10 minutes \\[and their associated days\\] should be re-coded to 'zero'"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Rehabilitation', 'Telerehabilitation', 'Secondary Prevention', 'Wearable Electronic Devices', 'Exercise Therapy'], 'conditions': ['Acute Coronary Syndrome', 'Cardiac Rehabilitation', 'Telerehabilitation', 'Secondary Prevention', 'Wearable Electronic Devices', 'Exercise Therapy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to establish an innovative Cardiac Tele-Rehabilitation (CTR) model. It could expands assistance resources through coordination with public administrations, developing a physical exercise program (PEP) assistance model in phase II that resolves the current situation of lack of adherence in the PEP due in part to the long waiting time to start it. To sum up this study could improve adherence in Cardiac Rehabilitation Phase III. It represents an opportunity to validate an innovative model for the realization of the PEP for phase II that could be expanded to other centres.', 'detailedDescription': 'Cardiac Rehabilitation (CR) programs show benefits in cardiovascular morbidity and mortality, exercise capacity, risk factors and quality of life. The use of new information and communication technologies (ICT) allows remote monitoring of activity and rhythm, defining a new model of cardiac tele-rehabilitation (CTR) and proving to be safe.\n\nThe investigators intend to evaluate a new model of CR in Phase II in acute coronary syndrome (ACS), based on the implementation of the physical exercise program (PEP) in a public sports centre (PSC) with tele-monitoring by means of a wearable electronic device, S-PATCH3-Cardio, to compare the adherence of a PEP based on a CTR-PSC model with the traditional in-hospital program (PEP-H) maintaining the efficacy and safety of the CR program.\n\nPatients with recent stratified ACS of low and / or moderate risk will be included who will be randomly assigned to the PEP-H group who will perform 18 PEP sessions with strength training and cardiorespiratory resistance in a hospital, or a CTR-PSC group that performs the 18 sessions of the PEP with strength training and cardiorespiratory resistance in the PSC.\n\nAll patients will perform the rest of the CR program at the hospital that it includes: functional tests, consultations with nurse, cardiologist, rehabilitation doctor, and the educational program, with 10 Workshops in a Cardio-healthy Classroom.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent ACS (1-12 months) of low / moderate risk for the realization of a PEP and without physical impediments for it\n* Availability of a mobile phone with Android operating system where you can install the S-PATCH3-Cardio application\n* Patients who recognize that they are trained to operate the S-PATCH3-Cardio device after being instructed in its operation and perform a 24-hour simulation.\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient\\> 1.1)\n* Mental disability\n* Associated comorbidity that prevents performing PEP'}, 'identificationModule': {'nctId': 'NCT04121702', 'briefTitle': 'Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model', 'orgStudyIdInfo': {'id': 'e-CARCEX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PEP-H', 'description': 'Physical exercise program at a hospital', 'interventionNames': ['Procedure: Cardiac Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'PEP-PSC', 'description': 'Physical exercise program with tele-monitoring in a public sport centre', 'interventionNames': ['Procedure: Cardiac Rehabilitation']}], 'interventions': [{'name': 'Cardiac Rehabilitation', 'type': 'PROCEDURE', 'description': 'Implementation of a physical exercise program (PEP) with tele-monitoring', 'armGroupLabels': ['PEP-H', 'PEP-PSC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Izquierdo Garcia, Therapist', 'role': 'CONTACT', 'email': 'juan.izquierdo@salud.madrid.org', 'phone': '+34917792077'}, {'name': 'Guillermo Moreno Muñoz, Nurse', 'role': 'CONTACT', 'email': 'guimoren@ucm.es', 'phone': '+34913908519'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Juan Izquierdo Garcia, Therapist', 'role': 'CONTACT', 'email': 'juan.izquierdo@salud.madrid.org', 'phone': '+34917792077'}, {'name': 'Guillermo Moreno Muñoz, Nurse', 'role': 'CONTACT', 'email': 'guimoren@ucm.es', 'phone': '+34913908519'}], 'overallOfficials': [{'name': 'Juan Izquierdo Garcia, Therapist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juan Izquierdo García', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Juan Izquierdo García, Physical Therapist, Principal Investigator', 'investigatorFullName': 'Juan Izquierdo García', 'investigatorAffiliation': 'Hospital Universitario 12 de Octubre'}}}}