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

NCT03541135 | Enrolling By Invitation

• 1 other identifier: Seniors-ENRICA II
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Disability; Cognitive Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (23)

• 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

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (1)

Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid

Madrid, 28029, Spain

Location

Related Publications (2)

• 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: 38730363 DERIVED

• 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.

  PMID: 37146761 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, urine

MeSH Terms

Conditions

Cognitive Dysfunction; Frailty

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando Rodríguez-Artalejo, MD, PhD

  Department of Preventive Medicine and Public Health. Universidad Autónoma de Madrid

  PRINCIPAL INVESTIGATOR

• Jose R Banegas, MD, PhD

  Department of Preventive Medicine and Public Health. Universidad Autónoma de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Preventive Medicine and Public Health

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: May 30, 2018
• Study Start: January 1, 2016
• Primary Completion: September 1, 2018
• Study Completion (Estimated): September 1, 2030
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

ES (1)