- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679026
The "Motoric Cognitive Risk" Syndrome in the Canadian Population (MCR-CardioV)
March 28, 2022 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
Active, not recruiting
Study Type
Observational
Enrollment (Anticipated)
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
-
-
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
Ages Eligible for Study
45 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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 |
Intervention / Treatment |
---|---|
CVRF
individuals with cardio-vascular risk factors and diseases
|
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
|
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
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
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
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)
August 22, 2017
Primary Completion (Actual)
August 21, 2021
Study Completion (Anticipated)
December 21, 2022
Study Registration Dates
First Submitted
August 21, 2018
First Submitted That Met QC Criteria
September 18, 2018
First Posted (Actual)
September 20, 2018
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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