The "Motoric Cognitive Risk" Syndrome in the Canadian Population (MCR-CardioV)

April 4, 2024 updated by: Olivier Beauchet, Jewish General Hospital

The "Motoric Cognitive Risk" Syndrome in the Canadian Population: Analysis of Baseline Assessment of the Canadian Longitudinal Study on Aging (CLSA)

Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that "motoric cognitive risk" (MCR) syndrome, which has been described in cognitively healthy individuals and combines subjective cognitive complaint with objective slow gait speed, is a pre-dementia syndrome. The uniqueness of "motoric cognitive risk" (MCR)syndrome is that it does not rely on a complex evaluation or laboratory investigations. Thus, it is easy to apply in population-based settings. The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, in the Quebec population using the database of the NuAge study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
1461

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

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital

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

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals eligible for this study will be participants of the comprehensive Canadian Longitudinal Study on Aging (n=30,097). They are separated in four age groups (i.e.; 45-54, 54-64, 65-74 and 75-85). Each group will be divided in two subgroups: individuals with and without cardio-vascular risk factors and diseases.

Description

Inclusion Criteria:

  • Individuals eligible for this study will be participants of the NuAge study

Exclusion Criteria:

  • Individuals not eligible for the NuAge study
  • dementia
  • mobility disability
  • no information about cognitive complaint
  • no measure of walking speed

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: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CVRF
individuals with cardio-vascular risk factors and diseases
Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentages
Participants' baseline characteristics will be summarized using means and standard deviations or frequencies and percentages, as appropriate.
WCVRF
individuals without cardio-vascular risk factors and diseases
Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentages
Participants' baseline characteristics will be summarized using means and standard deviations or frequencies and percentages, as appropriate.

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
Cardio-vascular risk factors and diseases assessed using reported health condition
Time Frame: 1 day
medical history
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardio-vascular risk factors and diseases assessed using physical examination: BMI
Time Frame: 1 day
body mass index
1 day
Cardio-vascular risk factors and diseases assessed using physical examination: HW ratio
Time Frame: 1 day
hip-waist ratio
1 day
Cardio-vascular risk factors and diseases assessed using physical examination: blood pressure
Time Frame: 1 day
(value of systolic, diastolic when participants are seated in an upright position in a chair)
1 day
Disability and functional limitations
Time Frame: 1 day
Disability and functional limitations : ADL (activities of daily life)
1 day
Disability and functional limitations
Time Frame: 1 day
Disability and functional limitations : IADL (instrumental activities of daily life)
1 day
Disability and functional limitations
Time Frame: 12 months
History of falls during the past 12 months
12 months
Depression
Time Frame: 1 day
measured by the 10 items of the Center for Epidemiological Studies Short Depression Scale. Participants with a score of 10 or greater are considered as depressed. Scores with more than 2 missing items will be excluded.
1 day
Cognitive performance
Time Frame: 1 day
Prospective Memory Test (PMT)
1 day
Cognitive performance
Time Frame: 1 day
Stroop Neurological Screening Test
1 day
Cognitive performance
Time Frame: 1 day
Controlled Oral Word Association Test (FAS)
1 day
Cognitive performance
Time Frame: 1 day
Choice Reaction Time Test (CRT)
1 day
physical and mental health
Time Frame: 1 day
Number of drugs daily taken
1 day
physical and mental health
Time Frame: 1 day
Self-perception of health and mental health
1 day
Physical performance
Time Frame: 1 day
Muscle strength estimated using the handgrip strength
1 day
Physical performance
Time Frame: 1 day
five-time sit-to-stand test
1 day
Physical performance
Time Frame: 1 day
Physical Activity Scale for the Elderly, scored between 0 and 400, low scores indicate sarcopenia
1 day

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.
Jewish General Hospital

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.
August 22, 2017

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.
August 21, 2021

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.
December 21, 2024

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).
August 21, 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.
September 18, 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.
September 20, 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.
April 5, 2024

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.
April 4, 2024

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.
April 1, 2024

More Information

Terms related to this study

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.
  • CODIM-FLP-16 261

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.

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