Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-10 @ 2:51 PM
Study NCT ID:
NCT03838003
Status:
COMPLETED
Last Update Posted:
2021-09-10
First Post:
2018-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise in Patients Admitted With Recently Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2018-11-15', 'studyFirstSubmitQcDate': '2019-02-08', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute walking test', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of meters walked in the 6 minute walking test'}], 'secondaryOutcomes': [{'measure': 'Barthel Index score', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Barthel evaluates dependence on self-care'}, {'measure': 'London Chest Activity of Daily Living (LCADL) scale score', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'LIDL accesses how dyspnea affects self-care'}, {'measure': 'Number of dysrhythmias during exercise in the training group', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To quantify the number of dysrhythmias during exercise in the training group'}, {'measure': 'Number of falls during exercise in the training group', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To quantify the number of falls during exercise in the training group'}, {'measure': 'Number of emergency situations during exercise in the training group', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To quantify the number of emergency situations during exercise in the training group'}, {'measure': 'Number of chest pain situations during exercise in the training group', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To quantify the chest pain situations during exercise in the training group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Rehabilitation Nursing', 'Functional capacity', 'Heart failure'], 'conditions': ['Decompensated Heart Failure', 'Functional Cardiac Disorder']}, 'referencesModule': {'references': [{'pmid': '32316758', 'type': 'DERIVED', 'citation': 'Delgado BM, Lopes I, Gomes B, Novo A. Early rehabilitation in cardiology - heart failure: The ERIC-HF protocol, a novel intervention to decompensated heart failure patients rehabilitation. Eur J Cardiovasc Nurs. 2020 Oct;19(7):592-599. doi: 10.1177/1474515120913806. Epub 2020 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program.', 'detailedDescription': "With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. Patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the ERIC protocol will be applied to the test group. The control group will be implemented the usual care of rehabilitation nursing. The ERIC protocol comprises 5 levels of intensity, as following shown: Stage 1 - respiratory and calisthenic exercises (5-10 minutes) Stage 2 - pedal for 5-10 minutes Stage 3 - aerobic training: walking on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for 10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. The investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity.\n\nPatients in the test group may start the program only on stage I or II according to clinical criteria. At admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to Barthel's indices and London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index and the LCADL scale will also be evaluated, as well as the 6-minute walking test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission diagnosis of Decompensated heart failure\n* More than 18 years old\n* Capacity to provide informed consent\n\nExclusion Criteria:\n\n* Osteoarticular pathology that impedes the performance of the exercise\n* Existence of inotropic infusions\n* Dysrhythmia or precordial pain in the last 24 hours\n* Acute pulmonary edema in the last 12 hours\n* Systolic blood pressure greater than 180millimetre of mercury (mmHg) or less than 80mmHg (except in cases where this is the baseline value for the patient)\n* Need for oxygen at a rate greater than 3 /min\n* Glycemic decompensation in the last 12 hours'}, 'identificationModule': {'nctId': 'NCT03838003', 'acronym': 'ERIC', 'briefTitle': 'Exercise in Patients Admitted With Recently Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Rehabilitation Nursing on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise', 'orgStudyIdInfo': {'id': 'ERIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Training group', 'description': 'Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol', 'interventionNames': ['Procedure: ERIC protocol']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention: Control group', 'description': 'Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients'}], 'interventions': [{'name': 'ERIC protocol', 'type': 'PROCEDURE', 'description': 'ERIC protocol is an aerobic exercise protocol with 5 levels of intensity', 'armGroupLabels': ['Experimental: Training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Hospitalar do Porto', 'class': 'OTHER'}, {'name': 'Instituto Politécnico de Bragança', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}