Clinical trial NCT04240028: The Cognitive-Prefrail Syndrome and Its Association With Adverse Health Outcomes
Official title: The Cognitive-Prefrail Syndrome and Its Association With Adverse Health Outcomes: Results From the NuAge Observational Population-based Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cognitive-prefrailty
Prefrailty
Motoric Cognitive Risk Syndrome
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 1741
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals eligible for this study will be participants of the NuAge study (n=1,793). All included participants of NuAge Study were healthy and, in particular, they were cognitively intact at baseline and had no mobility disability.

Brief summary: Lay Summary Older adults who are prefrail (an intermediate, potentially reversible stage between robustness and frailty) with early symptoms of cognitive impairment are a segment of the population that have hitherto remained "silent" and are currently not targets for screening and intervention. These individuals require early identification for preventive interventions to reduce disability, dependency and improve quality of life. To date, there is still no accepted definition of individuals upstream in the spectrum of physical frailty and cognitive impairment. Determining the prevalence and predictive ability of various definitions of co-existent frailty and cognitive impairment could identify older adults at greatest risk of adverse health outcomes. Therefore, the researchers aim to examine and compare (1) the prevalence of cognitive-prefrailty, prefrailty (IANA/IAGG consensus definition) and MCR syndromes, (2) the incidence and predictive ability of these three syndromes for adverse health outcomes including cognitive impairment and decline, dementia, physical functional impairment and decline, falls, hospitalization and mortality in older Quebec community dwellers.

Detailed description: Scientific Summary

Background Cognitive frailty is the simultaneous presence of both physical frailty and cognitive impairment, excluding concurrent dementia. This condition confers a greater risk of incident cognitive impairment and decline, dementia, falls and disabilities compared to either condition alone. Current definitions of co-existent frailty and cognitive impairment exist, including the International Academy on Nutrition and Aging (IANA) and the International Association of Gerontology and Geriatrics (IAGG) consensus for cognitive frailty. There is also an analogous construct known as the motoric cognitive risk syndrome (MCR) associating slow gait speed and subjective cognitive impairment (SCI). Current operational criteria identify individuals later in the trajectory of frailty and cognitive decline, which may be too late for effective interventions. The researchers propose to define a new and early condition in the spectrum of Cognitive frailty known as "cognitive-prefrailty", which is a combination of prefrailty stage and SCI.

Overall objective This study aims to determine and compare (1) the prevalence of cognitive-prefrailty, cognitive frailty (IANA/IAGG consensus definition) and MCR syndromes, (2) the incidence and predictive ability of these three syndromes for adverse health outcomes including cognitive impairment and decline, dementia, physical functional impairment and decline, falls, hospitalization and mortality in older community dwellers.

Methods This study will use the database of the "Nutrition as a determinant of successful aging: The Quebec longitudinal study" (NuAge) study, which is a population-based observational cohort hat recruited healthy community-dwellers with age ranged from 67 to 84 years (51.8% women) between November 2003 and June 2005, and followed them during 4 years. Cognitive-prefrailty, prefrailty and MCR will be defined using information collected at the baseline assessment. Incident adverse health outcomes including cognitive impairment and decline, dementia, physical functional impairment and decline, falls, hospitalization and mortality have been recorded during the 4-years follow-up period.

Anticipated results Prefrailty (an intermediate and potentially reversible stage between robust and frailty) and SCI occur upstream in the continuum of frailty and cognitive decline and hence constitute more suitable targets for screening and early intervention in older adults.

Eligibility criteria: Inclusion Criteria:

* Be participants of the NuAge study who agreed to be part of the NuAge Database and Biobank for future research purposes

Exclusion Criteria:

* Missing data at baseline and follow-up assessments
* Participants' refusal to use their data for a purpose not identified during their recruitment.

Primary outcomes:
measure: Cognitive impairment
timeFrame: 1 day
measure: Cognitive decline
timeFrame: 1 day
measure: Incident dementia
timeFrame: 1 day
measure: Physical functional impairment
timeFrame: 1 day
measure: Physical functional Decline
timeFrame: 1 day
measure: Falls
timeFrame: 1 day
measure: Hospitalizations
timeFrame: 1 day
measure: Mortality
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University, Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References: