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Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain

Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain (Seniors-ENRICA II)

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03541135
Acronym
Sen-ENRICAII
Enrollment
4000
Registered
2018-05-30
Start date
2016-01-31
Completion date
2030-09-30
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Physical Disability

Keywords

Cardiovascular health, Diet, Functional limitations, Frailty, Older Adults

Brief summary

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.

Interventions

None listed

Sponsors

Universidad Autonoma de Madrid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* Non-institutionalized residents in the region of Madrid, Spain. * 65 years and over

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Functional limitations on taste function3 yearsNIH Tool Box Taste test
Functional limitations on auditory function3 yearsAudiometry
Functional limitations on bicep-femoral flexibility3 yearsChair Sit and Reach test
Functional limitations on shoulder flexibility3 yearsBack Scratch test
Functional limitations on balance3 yearsShort Physical Performance Battery (SPPB): Balance test
Functional limitations on gait speed3 yearsShort Physical Performance Battery (SPPB): Gait Speed test
Functional limitations on strength of legs3 yearsShort Physical Performance Battery (SPPB): Chair Stand test
Functional limitations on strength of hands3 yearsHydraulic hand dynamometer (Jamar Plus +)
Functional limitations on activities of daily living3 yearsActivities of Daily Living (ADLs) test
Functional limitations on instrumental activities of daily living3 yearsInstrumental Activities of Daily Living (IADLs) test
Functional limitations on olfactory function3 yearsPocket Smell test
Cognitive impairment3 yearsMini-Mental State Examination (MMSE)
Executive function limitations on working memory3 yearsDigits Forward test (WAIS-III),
Executive function limitations on programmed motor tasks3 yearsThree Hand Position test of Luria
Executive function limitations on motor response control3 yearsGO-NO-GO test.
Memory function limitations3 yearsSeven Minute Screen (orientation, memory, clock drawing, verbal fluency)
Frailty3 yearsFried criteria
Falls3 yearsFrom the question: 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
Arterial stiffness estimated by pulse wave velocity (PWV)3 yearsAmbulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate PWV (m/s) over a 24 hours period
Arterial stiffness estimated by central sistolic blood pressure (CSBP)3 yearsAmbulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate CSBP (mmHg) over a 24 hours period
Arterial stiffness estimated by augmentation index (AI)3 yearsAmbulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate AI (%) over a 24 hours period
24-h systolic and diastolic blood pressure3 yearsAmbulatory 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
Mortality3 yearsFrom the National Institute of Statistics of Spain

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026