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Enrolling by invitationNCT03541135Sen-ENRICAIIUpdated Dec 20, 2023

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

An observational study in Physical Disability and Cognitive Dysfunction, sponsored by Universidad Autonoma de Madrid. Enrolling by invitation at 1 site in Spain. Open to participants aged 65 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by Universidad Autonoma de Madrid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
65 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Physical Disability
  • Cognitive Dysfunction

Keywords

  • Cardiovascular health
  • Diet
  • Functional limitations
  • Frailty
  • Older Adults
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Universidad Autonoma de Madrid is the lead sponsor of 51 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Functional limitations on bicep-femoral flexibility

    Chair Sit and Reach test

    Time frame: 3 years

  2. Functional limitations on shoulder flexibility

    Back Scratch test

    Time frame: 3 years

  3. Functional limitations on balance

    Short Physical Performance Battery (SPPB): Balance test

    Time frame: 3 years

  4. Functional limitations on gait speed

    Short Physical Performance Battery (SPPB): Gait Speed test

    Time frame: 3 years

  5. Functional limitations on strength of legs

    Short Physical Performance Battery (SPPB): Chair Stand test

    Time frame: 3 years

  6. Functional limitations on strength of hands

    Hydraulic hand dynamometer (Jamar Plus +)

    Time frame: 3 years

  7. Functional limitations on activities of daily living

    Activities of Daily Living (ADLs) test

    Time frame: 3 years

  8. Functional limitations on instrumental activities of daily living

    Instrumental Activities of Daily Living (IADLs) test

    Time frame: 3 years

  9. Functional limitations on olfactory function

    Pocket Smell test

    Time frame: 3 years

  10. Functional limitations on taste function

    NIH Tool Box Taste test

    Time frame: 3 years

  11. Functional limitations on auditory function

    Audiometry

    Time frame: 3 years

  12. Cognitive impairment

    Mini-Mental State Examination (MMSE)

    Time frame: 3 years

  13. Executive function limitations on working memory

    Digits Forward test (WAIS-III),

    Time frame: 3 years

  14. Executive function limitations on programmed motor tasks

    Three Hand Position test of Luria

    Time frame: 3 years

  15. Executive function limitations on motor response control

    GO-NO-GO test.

    Time frame: 3 years

  16. Memory function limitations

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

    Time frame: 3 years

  17. Frailty

    Fried criteria

    Time frame: 3 years

  18. 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

    Time frame: 3 years

  19. 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

    Time frame: 3 years

  20. 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

    Time frame: 3 years

  21. 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

    Time frame: 3 years

  22. 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

    Time frame: 3 years

  23. Mortality

    From the National Institute of Statistics of Spain

    Time frame: 3 years

07

Study locations

1 site
  • Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid
    Madrid, 28029, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Sep 2018, 32 months.

Of 504 non-industry observational studies under Cognitive Dysfunction, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 118. This study's 32 months is below that.

Counting every sponsor, half of 543 studies reached it within 47 months; a quarter within 21 and three quarters within 118.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2018
First posted
May 30, 2018
StartActual
Jan 2016
Primary completionActual
Sep 2018
CompletionEst.
Sep 2030
Last update
Dec 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03541135
Lead sponsor
Universidad Autonoma de Madrid
Responsible party
Fernando Rodríguez-Artalejo (Professor of Preventive Medicine and Public Health, Universidad Autonoma de Madrid) — Principal investigator
First posted
May 30, 2018
Start date
Jan 2016
Primary completion
Sep 2018
Completion
Sep 2030 (estimated)
Last update
Dec 20, 2023

Study contacts

Fernando Rodríguez-Artalejo, MD, PhD
principal investigator · Department of Preventive Medicine and Public Health. Universidad Autónoma de Madrid
Jose R Banegas, MD, PhD
principal investigator · Department of Preventive Medicine and Public Health. Universidad Autónoma de Madrid

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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