Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 3:38 PM
Study NCT ID:
NCT05070533
Status:
WITHDRAWN
Last Update Posted:
2023-06-13
First Post:
2021-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventions to Prevent Falls. PRECAISAL Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Because of Covid19', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-11', 'studyFirstSubmitDate': '2021-09-27', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of falls', 'timeFrame': '6 months', 'description': 'Number of falls in relation to the degree of physical activity'}, {'measure': 'Physical activity', 'timeFrame': '9 days', 'description': 'It will be evaluated with a digital pedometer'}, {'measure': 'Cost-effectiveness', 'timeFrame': '6 months', 'description': 'Evaluated by the incremental cost-effectiveness ratio'}, {'measure': 'Health effects', 'timeFrame': '6 months', 'description': 'They are measured using quality-adjusted life years (QALYs) based on the EQ-5D-5'}], 'secondaryOutcomes': [{'measure': 'Fear of falling', 'timeFrame': '6 months', 'description': 'It will be assessed using the Short Falls International Scale of Efficacy. This scale measures of "concerns about falling". This scale has 7 items with a Likert scale with 4 options: 1) not at all concerned, 2) somewhat concerned, 3) fairly concerned, and 4) very concerned.'}, {'measure': 'Adherence to exercise', 'timeFrame': '6 months', 'description': 'It will be assessed using the Exercise Adherence Rating Scale (EARS). This scale is composed of 16 items and they were scored using a 5-point Likert scale (0 = completely agree to 4 = completely disagree) with a possible summed score range from 0 to 64.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Accidental Falls', 'Old Age; Debility', 'Activity, Motor']}, 'descriptionModule': {'briefSummary': 'This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home.', 'detailedDescription': 'Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.\n\nThe study tries to assess whether a group intervention following the principles of the LiFE program is no less effective than individual intervention in reducing the incidence of falls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Older than 70 years\n* Live at your address\n* Are at risk of falls\n* Timed Up and Go Test time timed ≥ 12 seconds\n* Able to walk 200 meters without personal assistance\n* Speak and read in Spanish\n\nExclusion Criteria:\n\n* Perform moderate to vigorous physical activity\\> 150 min / week in the last 3 months\n* Present any of the following medical conditions:\n\n * Heart failure (New York Heart Association class III and IV)\n * Recent stroke (\\<6 months)\n * Parkinson's disease\n * In active cancer treatment (last 6 months)\n * Class III and IV chronic obstructive pulmonary disease\n * Unstable fracture of the lower limb\n * Lower limb amputated\n * Treatment for less than 6 months of depression\n * Uncontrolled resting blood pressure of a systolic pressure\\> 160 or a diastolic pressure\\> 100 or more\n * Not being available for home visits within 11 weeks of the initial assessment: having planned trips or transfers of more than 2 months within the first 6 months of the study\n * Moderate to severe cognitive impairment (Mini Mental cognitive assessment \\<23)\n * Current participation in another scientific intervention trial."}, 'identificationModule': {'nctId': 'NCT05070533', 'briefTitle': 'Interventions to Prevent Falls. PRECAISAL Study', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion y Formacion en Ciencias de la Salud'}, 'officialTitle': 'Interventions to Prevent Falls in Elderly People Who Live at Home. PRECAISAL Study', 'orgStudyIdInfo': {'id': 'GRS 1985/B/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Individual treatment', 'description': 'The strength and balance activities of the LiFE program will be carried out. Participants will receive 7 home visits and will be given the support material for the manual (diptychs, pictures, etc.).', 'interventionNames': ['Behavioral: Individual treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Groupal treatment', 'description': 'The strength and balance activities of the LiFE program will be carried out. Participants will be invited to participate in groups of about 8 - 12 people in community venues.', 'interventionNames': ['Behavioral: Groupal treatment']}], 'interventions': [{'name': 'Individual treatment', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 7 home visits to implement the program.', 'armGroupLabels': ['Individual treatment']}, {'name': 'Groupal treatment', 'type': 'BEHAVIORAL', 'description': 'Subjects will participate in groups of about 8 - 12 to implement the program.', 'armGroupLabels': ['Groupal treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37005', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Infosalud', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'overallOfficials': [{'name': 'Luis García-Ortiz', 'role': 'STUDY_CHAIR', 'affiliation': 'Primary Health Care Research Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion y Formacion en Ciencias de la Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}