Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-02 @ 7:59 AM
Study NCT ID:
NCT05865158
Status:
UNKNOWN
Last Update Posted:
2023-11-09
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CardioSafe+: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-06-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum inspiratory pressure by spirometry', 'timeFrame': '6 weeks', 'description': 'Value of the maximum inspiratory capacity in mm of H2O.'}, {'measure': 'Maximum expiratory pressure by spirometry', 'timeFrame': '6 weeks', 'description': 'Value of the maximum expiratory capacity in mm of H2O.'}, {'measure': 'Borg Rating of Perceived Exertion Scale', 'timeFrame': '6 weeks', 'description': 'Scale of perceived subjective effort in which it is valued with a score of 0 to 10, subjectively. Started from 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.'}, {'measure': '2 minute stationary walk test', 'timeFrame': '6 weeks', 'description': 'Effort test in which the participant is asked to lift their knees for 2 minutes and the number of times is counted. Based on that number, the percentile in which the person is based on their age and sex is calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The use of telerehabilitation seems to be effective in managing complications after suffering a cardiovascular pathology. The use of the CardioSafe+ digital platform is suggested for the management of these complications. For this reason, an intervention will be carried out to determine the effectiveness of this platform. A total of 60 participants will be recruited to carry out a home-exercise intervention through CardioSafe+ for 6 weeks. Maximun respiratory pressures, exertion capacity, and subjective sensation of exertion will be assessed.', 'detailedDescription': "This intervention seeks to determine the effectiveness of the CardioSafe+ digital platform in aiding individuals recovering from cardiovascular pathologies. By involving a group of 60 participants in a structured six-week home-exercise program using the CardioSafe+ platform, the objective is to measure and evaluate various factors related to their physical well-being and recovery.\n\nKey components to be evaluated include:\n\nMaximal Respiratory Pressures: This involves measuring the maximum force generated during inspiration and expiration, which can indicate respiratory muscle strength and function.\n\nExertion Capacity: The assessment aims to gauge the participants' ability to engage in physical activities, potentially reflecting improvements in overall cardiovascular fitness and endurance.\n\nSubjective Sensation of Exertion: This component involves understanding how the participants perceive and rate their own exertion during exercises, contributing to insights about their subjective experience and effort perception.\n\nThe intervention's objective is to collect data on these parameters before and after the six-week exercise program utilizing the CardioSafe+ digital platform. This data will help determine the effectiveness of the platform in aiding individuals recovering from cardiovascular pathologies and could provide valuable insights for further implementing tele-rehabilitation in managing such health complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People who present a cardiovascular pathology with more than one year of evolution.\n* To be in a stable medical situation.\n* To have access to technological resources and knowledge for their use.\n\nExclusion Criteria:\n\n* People who present any contraindication established for carrying out physical activity.\n* People who present insufficient capacity to understand and obey the instructions offered by the researchers, both in the evaluation and in the intervention.\n* People who have a cardiac pathology with obvious fluctuations in the course of the disease.\n* The presence of an acute episode of the disease during the intervention period.'}, 'identificationModule': {'nctId': 'NCT05865158', 'acronym': 'CardioSafe+', 'briefTitle': 'CardioSafe+: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'CardioSafe Plus: A Platform for Telerehabilitation and Monitoring of Patients With Heart Problems.', 'orgStudyIdInfo': {'id': 'CardioSafe+'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Institionalized group', 'description': 'Group of institutionalized people with chronic cardiovascular diseases.', 'interventionNames': ['Other: Home-based exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Community-dwelling group', 'description': 'Group of community-dwelling people with chronic cardiovascular diseases.', 'interventionNames': ['Other: Home-based exercises']}], 'interventions': [{'name': 'Home-based exercises', 'type': 'OTHER', 'description': 'Home-based exercises proposed through the CardioSafe+ platform, guided by therapists specialized in cardiovascular disorders, who will try to adapt the sessions to each participant.', 'armGroupLabels': ['Community-dwelling group', 'Institionalized group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Beatriz María Bermejo Gil, Dr.', 'role': 'CONTACT', 'email': 'beatriz.bermejo@usal.es', 'phone': '622289468'}, {'name': 'Fátima Perez Robledo', 'role': 'CONTACT', 'email': 'fatima_pr@usal.es', 'phone': '619885479'}, {'name': 'Beatriz María Bermejo Gil, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fátima Pérez Robledo, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luis Augusto Silva, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andre Sales Mendes, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anita Maria Rocha Fernandez, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hector Sanchez San Blas', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beatriz María Bermejo Gil', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'centralContacts': [{'name': 'Beatriz María Bermejo Gil, Dr', 'role': 'CONTACT', 'email': 'beatriz.bermejo@usal.es', 'phone': '622289468'}, {'name': 'Fátima Pérez Robledo', 'role': 'CONTACT', 'email': 'fatima_pr@usal.es', 'phone': '622289468'}], 'overallOfficials': [{'name': 'Beatriz María Bermejo Gil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Salamanca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Los datos de los participantes se trataran segun la Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor doctor', 'investigatorFullName': 'Beatriz-María Bermejo-Gil', 'investigatorAffiliation': 'University of Salamanca'}}}}