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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804672
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Fernando Rodríguez-Artalejo, Universidad Autonoma de Madrid

Brief 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).

Condition or disease
Physical Disability Cardiovascular Risk Factors

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Study Type : Observational
Actual Enrollment : 1566 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain
Actual Study Start Date : March 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : June 2017



Primary Outcome Measures :
  1. Change from baseline in Frailty [ Time Frame: 3 years ]
    Method of assessment: Fried criteria


Secondary Outcome Measures :
  1. Change from baseline in Cardiovascular health [ Time Frame: 3 years ]
    Method of assessment: 7 cardiovascular health metrics as defined by American Heart Association



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community-living individuals in Spain aged 60 years or older.
Criteria

Inclusion Criteria:

  • Non-institutionalized Spanish resident
  • 60 years and over

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804672


Locations
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Spain
Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid
Madrid, Spain, 28029
Sponsors and Collaborators
Universidad Autonoma de Madrid
Investigators
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Principal Investigator: Fernando Rodríguez-Artalejo, MD, PhD Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid
Principal Investigator: Jose R Banegas, MD, PhD Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernando Rodríguez-Artalejo, Professor of Preventive Medicine and Public Health, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT02804672    
Other Study ID Numbers: Seniors-ENRICA
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Keywords provided by Fernando Rodríguez-Artalejo, Universidad Autonoma de Madrid:
Cardiovascular health
Diet
Functional limitations
Frailty
Older adults
Additional relevant MeSH terms:
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Frailty
Pathologic Processes