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

• Conditions: Physical Disability; Cognitive Dysfunction

• Registration Number: NCT03541135
• Lead Sponsor: Universidad Autonoma de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Primary Completion: 2018-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20
• Study Completion: 2030-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid; 🇪🇸 Madrid, Spain