Study on Cardiovascular Health, Nutrition and Physical Functioning in Older Adults in Spain (Sen-ENRICAII)

December 14, 2023 updated by: Fernando Rodríguez-Artalejo, Universidad Autonoma de Madrid

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional limitations on bicep-femoral flexibility
Time Frame: 3 years
Chair Sit and Reach test
3 years
Functional limitations on shoulder flexibility
Time Frame: 3 years
Back Scratch test
3 years
Functional limitations on balance
Time Frame: 3 years
Short Physical Performance Battery (SPPB): Balance test
3 years
Functional limitations on gait speed
Time Frame: 3 years
Short Physical Performance Battery (SPPB): Gait Speed test
3 years
Functional limitations on strength of legs
Time Frame: 3 years
Short Physical Performance Battery (SPPB): Chair Stand test
3 years
Functional limitations on strength of hands
Time Frame: 3 years
Hydraulic hand dynamometer (Jamar Plus +)
3 years
Functional limitations on activities of daily living
Time Frame: 3 years
Activities of Daily Living (ADLs) test
3 years
Functional limitations on instrumental activities of daily living
Time Frame: 3 years
Instrumental Activities of Daily Living (IADLs) test
3 years
Functional limitations on olfactory function
Time Frame: 3 years
Pocket Smell test
3 years
Functional limitations on taste function
Time Frame: 3 years
NIH Tool Box Taste test
3 years
Functional limitations on auditory function
Time Frame: 3 years
Audiometry
3 years
Cognitive impairment
Time Frame: 3 years
Mini-Mental State Examination (MMSE)
3 years
Executive function limitations on working memory
Time Frame: 3 years
Digits Forward test (WAIS-III),
3 years
Executive function limitations on programmed motor tasks
Time Frame: 3 years
Three Hand Position test of Luria
3 years
Executive function limitations on motor response control
Time Frame: 3 years
GO-NO-GO test.
3 years
Memory function limitations
Time Frame: 3 years
Seven Minute Screen (orientation, memory, clock drawing, verbal fluency)
3 years
Frailty
Time Frame: 3 years
Fried criteria
3 years
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
3 years
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
3 years
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
3 years
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
3 years
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
3 years
Mortality
Time Frame: 3 years
From the National Institute of Statistics of Spain
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fernando Rodríguez-Artalejo, MD, PhD, Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid
  • Principal Investigator: Jose R Banegas, MD, PhD, Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Seniors-ENRICA II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings