Clinical trial NCT03541135: Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain
Official title: Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain (Seniors-ENRICA II)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Physical Disability
Cognitive Dysfunction
Keywords: Cardiovascular health
Diet
Functional limitations
Frailty
Older Adults
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 4000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-living individuals in the region of Madrid, Spain, aged 65 years or older.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Functional limitations on bicep-femoral flexibility
timeFrame: 3 years
measure: Functional limitations on shoulder flexibility
timeFrame: 3 years
measure: Functional limitations on balance
timeFrame: 3 years
measure: Functional limitations on gait speed
timeFrame: 3 years
measure: Functional limitations on strength of legs
timeFrame: 3 years
measure: Functional limitations on strength of hands
timeFrame: 3 years
measure: Functional limitations on activities of daily living
timeFrame: 3 years
measure: Functional limitations on instrumental activities of daily living
timeFrame: 3 years
measure: Functional limitations on olfactory function
timeFrame: 3 years
measure: Functional limitations on taste function
timeFrame: 3 years
measure: Functional limitations on auditory function
timeFrame: 3 years
measure: Cognitive impairment
timeFrame: 3 years
measure: Executive function limitations on working memory
timeFrame: 3 years
measure: Executive function limitations on programmed motor tasks
timeFrame: 3 years
measure: Executive function limitations on motor response control
timeFrame: 3 years
measure: Memory function limitations
timeFrame: 3 years
measure: Frailty
timeFrame: 3 years
measure: Falls
timeFrame: 3 years
measure: Arterial stiffness estimated by pulse wave velocity (PWV)
timeFrame: 3 years
measure: Arterial stiffness estimated by central sistolic blood pressure (CSBP)
timeFrame: 3 years
measure: Arterial stiffness estimated by augmentation index (AI)
timeFrame: 3 years
measure: 24-h systolic and diastolic blood pressure
timeFrame: 3 years
measure: Mortality
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid
Study officials:
affiliation: Department of Preventive Medicine and Public Health. Universidad Autónoma de Madrid
name: Fernando Rodríguez-Artalejo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Preventive Medicine and Public Health. Universidad Autónoma de Madrid
name: Jose R Banegas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: