Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT03541135
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-20
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional limitations on bicep-femoral flexibility', 'timeFrame': '3 years', 'description': 'Chair Sit and Reach test'}, {'measure': 'Functional limitations on shoulder flexibility', 'timeFrame': '3 years', 'description': 'Back Scratch test'}, {'measure': 'Functional limitations on balance', 'timeFrame': '3 years', 'description': 'Short Physical Performance Battery (SPPB): Balance test'}, {'measure': 'Functional limitations on gait speed', 'timeFrame': '3 years', 'description': 'Short Physical Performance Battery (SPPB): Gait Speed test'}, {'measure': 'Functional limitations on strength of legs', 'timeFrame': '3 years', 'description': 'Short Physical Performance Battery (SPPB): Chair Stand test'}, {'measure': 'Functional limitations on strength of hands', 'timeFrame': '3 years', 'description': 'Hydraulic hand dynamometer (Jamar Plus +)'}, {'measure': 'Functional limitations on activities of daily living', 'timeFrame': '3 years', 'description': 'Activities of Daily Living (ADLs) test'}, {'measure': 'Functional limitations on instrumental activities of daily living', 'timeFrame': '3 years', 'description': 'Instrumental Activities of Daily Living (IADLs) test'}, {'measure': 'Functional limitations on olfactory function', 'timeFrame': '3 years', 'description': 'Pocket Smell test'}, {'measure': 'Functional limitations on taste function', 'timeFrame': '3 years', 'description': 'NIH Tool Box Taste test'}, {'measure': 'Functional limitations on auditory function', 'timeFrame': '3 years', 'description': 'Audiometry'}, {'measure': 'Cognitive impairment', 'timeFrame': '3 years', 'description': 'Mini-Mental State Examination (MMSE)'}, {'measure': 'Executive function limitations on working memory', 'timeFrame': '3 years', 'description': 'Digits Forward test (WAIS-III),'}, {'measure': 'Executive function limitations on programmed motor tasks', 'timeFrame': '3 years', 'description': 'Three Hand Position test of Luria'}, {'measure': 'Executive function limitations on motor response control', 'timeFrame': '3 years', 'description': 'GO-NO-GO test.'}, {'measure': 'Memory function limitations', 'timeFrame': '3 years', 'description': 'Seven Minute Screen (orientation, memory, clock drawing, verbal fluency)'}, {'measure': 'Frailty', 'timeFrame': '3 years', 'description': 'Fried criteria'}, {'measure': 'Falls', 'timeFrame': '3 years', 'description': 'From the question:\n\n"How many times have you fallen down since the last interview? a) Number of falls; b) Number of injurious falls; c) Number of falls with fracture'}, {'measure': 'Arterial stiffness estimated by pulse wave velocity (PWV)', 'timeFrame': '3 years', 'description': 'Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate PWV (m/s) over a 24 hours period'}, {'measure': 'Arterial stiffness estimated by central sistolic blood pressure (CSBP)', 'timeFrame': '3 years', 'description': 'Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate CSBP (mmHg) over a 24 hours period'}, {'measure': 'Arterial stiffness estimated by augmentation index (AI)', 'timeFrame': '3 years', 'description': 'Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate AI (%) over a 24 hours period'}, {'measure': '24-h systolic and diastolic blood pressure', 'timeFrame': '3 years', 'description': 'Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate brachial blood pressure (systolic and diastolic) (mmHg) over a 24 hours period'}, {'measure': 'Mortality', 'timeFrame': '3 years', 'description': 'From the National Institute of Statistics of Spain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular health', 'Diet', 'Functional limitations', 'Frailty', 'Older Adults'], 'conditions': ['Physical Disability', 'Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '38730363', 'type': 'DERIVED', 'citation': 'Marcos-Delgado A, Yevenes-Briones H, Fernandez-Villa T, Martin-Sanchez V, Guallar-Castillon P, Rodriguez-Artalejo F, Lopez-Garcia E. Association between diet quality and malnutrition: pooled results from two population-based studies in older adults. BMC Geriatr. 2024 May 10;24(1):417. doi: 10.1186/s12877-024-04984-5.'}, {'pmid': '37146761', 'type': 'DERIVED', 'citation': 'Vega-Cabello V, Struijk EA, Caballero FF, Lana A, Arias-Fernandez L, Banegas JR, Rodriguez-Artalejo F, Lopez-Garcia E. Dietary Micronutrient Adequacy and Risk of Multimorbidity in Community-dwelling Older Adults. Am J Clin Nutr. 2023 Jul;118(1):34-40. doi: 10.1016/j.ajcnut.2023.05.008. Epub 2023 May 3.'}]}, 'descriptionModule': {'briefSummary': 'Population aging makes it necessary to identify factors related to unhealthy aging. The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles and biological risk factors (either clasical or emergent) and the risk of physical and cognitive function impairment and mortality in a cohort of community-living individuals aged 65 years and over.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community-living individuals in the region of Madrid, Spain, aged 65 years or older.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-institutionalized residents in the region of Madrid, Spain.\n* 65 years and over\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03541135', 'acronym': 'Sen-ENRICAII', 'briefTitle': 'Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Madrid'}, 'officialTitle': 'Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain (Seniors-ENRICA II)', 'orgStudyIdInfo': {'id': 'Seniors-ENRICA II'}}, 'contactsLocationsModule': {'locations': [{'zip': '28029', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Fernando Rodríguez-Artalejo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Preventive Medicine and Public Health. Universidad Autónoma de Madrid'}, {'name': 'Jose R Banegas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Preventive Medicine and Public Health. Universidad Autónoma de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Preventive Medicine and Public Health', 'investigatorFullName': 'Fernando Rodríguez-Artalejo', 'investigatorAffiliation': 'Universidad Autonoma de Madrid'}}}}