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Enrolling by Invitation

NCT Number: NCT03541135

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

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.

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Key information

Conditions

Physical Disability Cognition Disorders Cognitive Dysfunction Frailty Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Madrid, 28029, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Functional limitations on bicep-femoral flexibility

    Time frame: 3 years

    Chair Sit and Reach test

  2. Functional limitations on shoulder flexibility

    Time frame: 3 years

    Back Scratch test

  3. Functional limitations on balance

    Time frame: 3 years

    Short Physical Performance Battery (SPPB): Balance test

  4. Functional limitations on gait speed

    Time frame: 3 years

    Short Physical Performance Battery (SPPB): Gait Speed test

  5. Functional limitations on strength of legs

    Time frame: 3 years

    Short Physical Performance Battery (SPPB): Chair Stand test

  6. Functional limitations on strength of hands

    Time frame: 3 years

    Hydraulic hand dynamometer (Jamar Plus +)

  7. Functional limitations on activities of daily living

    Time frame: 3 years

    Activities of Daily Living (ADLs) test

  8. Functional limitations on instrumental activities of daily living

    Time frame: 3 years

    Instrumental Activities of Daily Living (IADLs) test

  9. Functional limitations on olfactory function

    Time frame: 3 years

    Pocket Smell test

  10. Functional limitations on taste function

    Time frame: 3 years

    NIH Tool Box Taste test

  11. Functional limitations on auditory function

    Time frame: 3 years

    Audiometry

  12. Cognitive impairment

    Time frame: 3 years

    Mini-Mental State Examination (MMSE)

  13. Executive function limitations on working memory

    Time frame: 3 years

    Digits Forward test (WAIS-III),

  14. Executive function limitations on programmed motor tasks

    Time frame: 3 years

    Three Hand Position test of Luria

  15. Executive function limitations on motor response control

    Time frame: 3 years

    GO-NO-GO test.

  16. Memory function limitations

    Time frame: 3 years

    Seven Minute Screen (orientation, memory, clock drawing, verbal fluency)

  17. Frailty

    Time frame: 3 years

    Fried criteria

  18. Falls

    Time frame: 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

  19. Arterial stiffness estimated by pulse wave velocity (PWV)

    Time frame: 3 years

    Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate PWV (m/s) over a 24 hours period

  20. Arterial stiffness estimated by central sistolic blood pressure (CSBP)

    Time frame: 3 years

    Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate CSBP (mmHg) over a 24 hours period

  21. Arterial stiffness estimated by augmentation index (AI)

    Time frame: 3 years

    Ambulatory Blood Pressure Monitor using the oscillometric method (Mobil-O-Graph PWA) to estimate AI (%) over a 24 hours period

  22. 24-h systolic and diastolic blood pressure

    Time frame: 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

  23. Mortality

    Time frame: 3 years

    From the National Institute of Statistics of Spain

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Registry information

Official study title

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

Acronym: Sen-ENRICAII

Important dates

Study start
2016
Primary completion
2018
Study completion
2030
First posted
May 30, 2018
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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