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Clinical Trials/NCT03541135
NCT03541135
Enrolling by Invitation
N/A

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

Universidad Autonoma de Madrid1 site in 1 country4,000 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Disability
Sponsor
Universidad Autonoma de Madrid
Enrollment
4000
Locations
1
Primary Endpoint
Executive function limitations on motor response control
Status
Enrolling by Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
September 2030
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fernando Rodríguez-Artalejo

Professor of Preventive Medicine and Public Health

Universidad Autonoma de Madrid

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Executive function limitations on motor response control

Time Frame: 3 years

GO-NO-GO test.

Functional limitations on balance

Time Frame: 3 years

Short Physical Performance Battery (SPPB): Balance test

Functional limitations on strength of legs

Time Frame: 3 years

Short Physical Performance Battery (SPPB): Chair Stand test

Functional limitations on activities of daily living

Time Frame: 3 years

Activities of Daily Living (ADLs) test

Functional limitations on instrumental activities of daily living

Time Frame: 3 years

Instrumental Activities of Daily Living (IADLs) test

Functional limitations on olfactory function

Time Frame: 3 years

Pocket Smell test

Cognitive impairment

Time Frame: 3 years

Mini-Mental State Examination (MMSE)

Frailty

Time Frame: 3 years

Fried criteria

Arterial stiffness estimated by central sistolic blood pressure (CSBP)

Time Frame: 3 years

Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate CSBP (mmHg) over a 24 hours period

Mortality

Time Frame: 3 years

From the National Institute of Statistics of Spain

Functional limitations on strength of hands

Time Frame: 3 years

Hydraulic hand dynamometer (Jamar Plus +)

Falls

Time Frame: 3 years

From 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

Functional limitations on shoulder flexibility

Time Frame: 3 years

Back Scratch test

Functional limitations on gait speed

Time Frame: 3 years

Short Physical Performance Battery (SPPB): Gait Speed test

Memory function limitations

Time Frame: 3 years

Seven Minute Screen (orientation, memory, clock drawing, verbal fluency)

Functional limitations on bicep-femoral flexibility

Time Frame: 3 years

Chair Sit and Reach test

Functional limitations on taste function

Time Frame: 3 years

NIH Tool Box Taste test

Functional limitations on auditory function

Time Frame: 3 years

Audiometry

Executive function limitations on working memory

Time Frame: 3 years

Digits Forward test (WAIS-III),

Executive function limitations on programmed motor tasks

Time Frame: 3 years

Three Hand Position test of Luria

Arterial stiffness estimated by augmentation index (AI)

Time Frame: 3 years

Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate AI (%) over a 24 hours period

Arterial stiffness estimated by pulse wave velocity (PWV)

Time Frame: 3 years

Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate PWV (m/s) over a 24 hours period

24-h systolic and diastolic blood pressure

Time Frame: 3 years

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

Study Sites (1)

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