Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain (Sen-ENRICAII)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cognitive Dysfunction; Physical Disability

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28029
    • Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Community-living individuals in the region of Madrid, Spain, aged 65 years or older.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional limitations on bicep-femoral flexibility	Chair Sit and Reach test	3 years
Functional limitations on shoulder flexibility	Back Scratch test	3 years
Functional limitations on balance	Short Physical Performance Battery (SPPB): Balance test	3 years
Functional limitations on gait speed	Short Physical Performance Battery (SPPB): Gait Speed test	3 years
Functional limitations on strength of legs	Short Physical Performance Battery (SPPB): Chair Stand test	3 years
Functional limitations on strength of hands	Hydraulic hand dynamometer (Jamar Plus +)	3 years
Functional limitations on activities of daily living	Activities of Daily Living (ADLs) test	3 years
Functional limitations on instrumental activities of daily living	Instrumental Activities of Daily Living (IADLs) test	3 years
Functional limitations on olfactory function	Pocket Smell test	3 years
Functional limitations on taste function	NIH Tool Box Taste test	3 years
Functional limitations on auditory function	Audiometry	3 years
Cognitive impairment	Mini-Mental State Examination (MMSE)	3 years
Executive function limitations on working memory	Digits Forward test (WAIS-III),	3 years
Executive function limitations on programmed motor tasks	Three Hand Position test of Luria	3 years
Executive function limitations on motor response control	GO-NO-GO test.	3 years
Memory function limitations	Seven Minute Screen (orientation, memory, clock drawing, verbal fluency)	3 years
Frailty	Fried criteria	3 years
Falls	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	3 years
Arterial stiffness estimated by pulse wave velocity (PWV)	Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate PWV (m/s) over a 24 hours period	3 years
Arterial stiffness estimated by central sistolic blood pressure (CSBP)	Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate CSBP (mmHg) over a 24 hours period	3 years
Arterial stiffness estimated by augmentation index (AI)	Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate AI (%) over a 24 hours period	3 years
24-h systolic and diastolic blood pressure	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	3 years
Mortality	From the National Institute of Statistics of Spain	3 years

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid
• Investigators: Principal Investigator: Fernando Rodríguez-Artalejo, MD, PhD, Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid; Principal Investigator: Jose R Banegas, MD, PhD, Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Older Adults; Diet; Frailty; Cardiovascular health; Functional limitations
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Seniors-ENRICA II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No