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Physical DisabilitySeniors-ENRICANCT02804672

Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles, biological risk factors, either well-established or emergent, and the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16). Read more about this study

Who is it for?
Ages 60 years and older
How many people
1,566 participants
Where
1 siteSpain
Study dates
Mar 2008to Jun 2017
Phase
Observational
Are there results?
None posted in the registry

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Community-living individuals in Spain aged 60 years or older.

Who may be able to join

  • Non-institutionalized Spanish resident
  • 60 years and over

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid

    Madrid, 28029

Other trials in Spain

About this study

The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles, biological risk factors, either well-established or emergent, and the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).

Keywords
Cardiovascular health, Diet, Functional limitations, Frailty, Older adults
Medical subject headings
Frailty

What is being measured

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

  1. Change from baseline in Frailty

    Method of assessment: Fried criteria

    Measured: 3 years

Secondary outcomes (1)

  1. Change from baseline in Cardiovascular health

    Method of assessment: 7 cardiovascular health metrics as defined by American Heart Association

    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 posted17 Jun 2016 (estimated)
  2. Study startMar 2008
  3. Primary completionOct 2010
  4. Study completionJun 2017

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
1,566 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02804672
Sponsor's protocol ID
Seniors-ENRICA
Acronym
Seniors-ENRICA
Status last verified
Apr 2019
First submitted
14 Jun 2016
Last updated
1 May 2019
Results posted
No

Publications

  • Banegas JR, de la Cruz JJ, Graciani A, Lopez-Garcia E, Gijon-Conde T, Ruilope LM, Rodriguez-Artalejo F. Impact of Ambulatory Blood Pressure Monitoring on Reclassification of Hypertension Prevalence and Control in Older People in Spain. J Clin Hypertens (Greenwich). 2015 Jun;17(6):453-61. doi: 10.1111/jch.12525. Epub 2015 Mar 16.

    PubMed 25779903

  • Garcia-Esquinas E, Graciani A, Guallar-Castillon P, Lopez-Garcia E, Rodriguez-Manas L, Rodriguez-Artalejo F. Diabetes and risk of frailty and its potential mechanisms: a prospective cohort study of older adults. J Am Med Dir Assoc. 2015 Sep 1;16(9):748-54. doi: 10.1016/j.jamda.2015.04.008. Epub 2015 May 16.

    PubMed 25986874

  • Lana A, Rodriguez-Artalejo F, Lopez-Garcia E. Dairy Consumption and Risk of Frailty in Older Adults: A Prospective Cohort Study. J Am Geriatr Soc. 2015 Sep;63(9):1852-60. doi: 10.1111/jgs.13626. Epub 2015 Aug 27.

    PubMed 26311353

  • Sandoval-Insausti H, Perez-Tasigchana RF, Lopez-Garcia E, Garcia-Esquinas E, Rodriguez-Artalejo F, Guallar-Castillon P. Macronutrients Intake and Incident Frailty in Older Adults: A Prospective Cohort Study. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1329-34. doi: 10.1093/gerona/glw033. Epub 2016 Mar 4.

    PubMed 26946103

  • Graciani A, Garcia-Esquinas E, Lopez-Garcia E, Banegas JR, Rodriguez-Artalejo F. Ideal Cardiovascular Health and Risk of Frailty in Older Adults. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):239-45. doi: 10.1161/CIRCOUTCOMES.115.002294. Epub 2016 May 10.

    PubMed 27166207

  • Vazquez-Fernandez A, Caballero FF, Yevenes-Briones H, Struijk EA, Baylin A, Fung TT, Lopez-Garcia E. Plant and Animal Protein Intake and Transitions From Multimorbidity to Frailty and Mortality in Older Adults. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13729. doi: 10.1002/jcsm.13729.

    PubMed 39971333

  • 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

  • Delgado-Velandia M, Maroto-Rodriguez J, Ortola R, Garcia-Esquinas E, Rodriguez-Artalejo F, Sotos-Prieto M. Plant-Based Diets and All-cause and Cardiovascular Mortality in a Nationwide Cohort in Spain: The ENRICA Study. Mayo Clin Proc. 2022 Nov;97(11):2005-2015. doi: 10.1016/j.mayocp.2022.06.008.

    PubMed 36333014

  • Sotos-Prieto M, Ortola R, Lopez-Garcia E, Rodriguez-Artalejo F, Garcia-Esquinas E. Adherence to the Mediterranean Diet and Physical Resilience in Older Adults: The Seniors-ENRICA Cohort. J Gerontol A Biol Sci Med Sci. 2021 Feb 25;76(3):505-512. doi: 10.1093/gerona/glaa277.

    PubMed 33152061

  • Garcia-Esquinas E, Rodriguez-Sanchez I, Ortola R, Lopez-Garcia E, Caballero FF, Rodriguez-Manas L, Banegas JR, Rodriguez-Artalejo F. Gender Differences in Pain Risk in Old Age: Magnitude and Contributors. Mayo Clin Proc. 2019 Sep;94(9):1707-1717. doi: 10.1016/j.mayocp.2019.03.034.

    PubMed 31486377

  • Sandoval-Insausti H, Blanco-Rojo R, Graciani A, Lopez-Garcia E, Moreno-Franco B, Laclaustra M, Donat-Vargas C, Ordovas JM, Rodriguez-Artalejo F, Guallar-Castillon P. Ultra-processed Food Consumption and Incident Frailty: A Prospective Cohort Study of Older Adults. J Gerontol A Biol Sci Med Sci. 2020 May 22;75(6):1126-1133. doi: 10.1093/gerona/glz140.

    PubMed 31132092

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Disability and Cardiovascular Risk Factors, 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: finished, as of the sponsor's last update on 1 May 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in Frailty (time frame: 3 years). 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 NCT02804672, which also lists 11 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 1 May 2019.

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