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

Cognitive Dysfunction Clinical Trial

— Sen-ENRICAII  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03541135
• Other study ID #: Seniors-ENRICA II
• Status: Enrolling by invitation
• Start date: January 2016
• Est. completion date: September 2030

Study information

• Verified date: December 2023
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4000
• Est. completion date: September 2030
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Physical Disability

Locations

Country	Name	City	State
Spain	Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional limitations on bicep-femoral flexibility	Chair Sit and Reach test	3 years
Primary	Functional limitations on shoulder flexibility	Back Scratch test	3 years
Primary	Functional limitations on balance	Short Physical Performance Battery (SPPB): Balance test	3 years
Primary	Functional limitations on gait speed	Short Physical Performance Battery (SPPB): Gait Speed test	3 years
Primary	Functional limitations on strength of legs	Short Physical Performance Battery (SPPB): Chair Stand test	3 years
Primary	Functional limitations on strength of hands	Hydraulic hand dynamometer (Jamar Plus +)	3 years
Primary	Functional limitations on activities of daily living	Activities of Daily Living (ADLs) test	3 years
Primary	Functional limitations on instrumental activities of daily living	Instrumental Activities of Daily Living (IADLs) test	3 years
Primary	Functional limitations on olfactory function	Pocket Smell test	3 years
Primary	Functional limitations on taste function	NIH Tool Box Taste test	3 years
Primary	Functional limitations on auditory function	Audiometry	3 years
Primary	Cognitive impairment	Mini-Mental State Examination (MMSE)	3 years
Primary	Executive function limitations on working memory	Digits Forward test (WAIS-III),	3 years
Primary	Executive function limitations on programmed motor tasks	Three Hand Position test of Luria	3 years
Primary	Executive function limitations on motor response control	GO-NO-GO test.	3 years
Primary	Memory function limitations	Seven Minute Screen (orientation, memory, clock drawing, verbal fluency)	3 years
Primary	Frailty	Fried criteria	3 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Mortality	From the National Institute of Statistics of Spain	3 years