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Physical DisabilitySen-ENRICAIINCT03541135

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

An observational study of Physical Disability and Cognitive Dysfunction, run by Universidad Autonoma de Madrid at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 65 to 95 years
Conditions the study is for
Physical Disability, Cognitive Dysfunction
How many people
4,000 participants
Where
1 siteSpain
Study dates
Jan 2016to Sep 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 95 years
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

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

    Madrid, 28029

Other trials in Spain

About this study

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

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.

Keywords
Cardiovascular health, Diet, Functional limitations, Frailty, Older Adults
Medical subject headings
Cognitive Dysfunction, Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional limitations on bicep-femoral flexibility

    Chair Sit and Reach test

    Measured: 3 years

  2. Functional limitations on shoulder flexibility

    Back Scratch test

    Measured: 3 years

  3. Functional limitations on balance

    Short Physical Performance Battery (SPPB): Balance test

    Measured: 3 years

  4. Functional limitations on gait speed

    Short Physical Performance Battery (SPPB): Gait Speed test

    Measured: 3 years

  5. Functional limitations on strength of legs

    Short Physical Performance Battery (SPPB): Chair Stand test

    Measured: 3 years

  6. Functional limitations on strength of hands

    Hydraulic hand dynamometer (Jamar Plus +)

    Measured: 3 years

  7. Functional limitations on activities of daily living

    Activities of Daily Living (ADLs) test

    Measured: 3 years

  8. Functional limitations on instrumental activities of daily living

    Instrumental Activities of Daily Living (IADLs) test

    Measured: 3 years

  9. Functional limitations on olfactory function

    Pocket Smell test

    Measured: 3 years

  10. Functional limitations on taste function

    NIH Tool Box Taste test

    Measured: 3 years

  11. Functional limitations on auditory function

    Audiometry

    Measured: 3 years

  12. Cognitive impairment

    Mini-Mental State Examination (MMSE)

    Measured: 3 years

  13. Executive function limitations on working memory

    Digits Forward test (WAIS-III),

    Measured: 3 years

  14. Executive function limitations on programmed motor tasks

    Three Hand Position test of Luria

    Measured: 3 years

  15. Executive function limitations on motor response control

    GO-NO-GO test.

    Measured: 3 years

  16. Memory function limitations

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

    Measured: 3 years

  17. Frailty

    Fried criteria

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 3 years

  23. Mortality

    From the National Institute of Statistics of Spain

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2018
  2. Study startJan 2016
  3. Primary completionSep 2018
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03541135
Sponsor's protocol ID
Seniors-ENRICA II
Acronym
Sen-ENRICAII
Status last verified
Dec 2023
First submitted
20 Mar 2018
Last updated
20 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Marcos-Delgado A, Yevenes-Briones H, Fernandez-Villa T, Martin-Sanchez V, Guallar-Castillon P, Rodriguez-Artalejo F, Lopez-Garcia E. Association between diet quality and malnutrition: pooled results from two population-based studies in older adults. BMC Geriatr. 2024 May 10;24(1):417. doi: 10.1186/s12877-024-04984-5.

    PubMed 38730363

  • Vega-Cabello V, Struijk EA, Caballero FF, Lana A, Arias-Fernandez L, Banegas JR, Rodriguez-Artalejo F, Lopez-Garcia E. Dietary Micronutrient Adequacy and Risk of Multimorbidity in Community-dwelling Older Adults. Am J Clin Nutr. 2023 Jul;118(1):34-40. doi: 10.1016/j.ajcnut.2023.05.008. Epub 2023 May 3.

    PubMed 37146761

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Disability and Cognitive Dysfunction, run by Universidad Autonoma de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional limitations on bicep-femoral flexibility (time frame: 3 years). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03541135, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.

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