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The Cognitive-Prefrail Syndrome and Its Association With Adverse Health Outcomes

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ClinicalTrials.gov Identifier: NCT04240028
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Olivier Beauchet, Jewish General Hospital

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.

Condition or disease Intervention/treatment
Cognitive-prefrailty Prefrailty Motoric Cognitive Risk Syndrome Other: Data Collection

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.

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Study Type : Observational
Estimated Enrollment : 1741 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Cognitive-Prefrail Syndrome and Its Association With Adverse Health Outcomes: Results From the NuAge Observational Population-based Study
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022

Group/Cohort Intervention/treatment
Individuals with prefrailty
This is defined as a co-existing prefrailty using the Fried criteria. Frailty defined by the CHS index as proposed by Fried et al. will be identified by the presence of ≥ 3 of the following 5 components: 1) Shrinking as identified by an unintentional weight loss of ≥ 5% between two assessments, 2) Weakness as identified by a maximal grip strength in the lowest quintile stratified by body mass index quartile; 3) Poor energy as identified by an answer of "no" to the question "Do you feel full of energy?" from the 30-item Geriatric Depression Scale; 4) Slowness as identified by an average walk speed in the lowest quintile stratified by median standing height, and 5) Low physical activity level as identified by a PASE score in the lowest quintile. Participants with none of the above components will be considered to be vigorous and those with 1 or 2 components will be considered to be in a prefrail stage.
Other: Data Collection
The NuAge study has been designed to investigate nutrition as a determinant of successful aging in older men and women in Quebec. This study is based on a population-based observational cohort design that initially recruited healthy community-dwellers with age ranged from 67 to 82 years (51.8% women) between January 2004 and April 2005. All participants lived in the areas of Montreal, Laval, and Sherbrooke in the Province of Quebec, Canada. After recruitment, they have been followed for 3 years with one clinical follow-up assessment each year (i.e.; 4 data collection time). A previous analysis performed on the NuAge study database has shown a significant decline of physical and cognitive performances with time (respectively an average of 10% and 2%), participants with lower physical performance showing lower cognitive performance.

Individuals with cognitive-prefrailty

A combination of prefrailty stage using Fried criteria and subjective cognitive impairment (SCI).

The IANA/IAGG consensus defines cognitive frailty as CDR = 0.5 and frailty by the Fried criteria.SCI will be defined using a proxy for subjective cognitive complaint (i.e. memory complaint) and following the procedure used in previous multicenter prevalence studies on MCR syndrome. Memory complaint used to define MCR syndrome was based on standardized memory loss question on the 15-item or 30-item Geriatric Depression Scale (GDS; "Do you feel you have more problems with memory than most?"). Memory complaint in our study will be elicited from this item of 30-item GDS.

Other: Data Collection
The NuAge study has been designed to investigate nutrition as a determinant of successful aging in older men and women in Quebec. This study is based on a population-based observational cohort design that initially recruited healthy community-dwellers with age ranged from 67 to 82 years (51.8% women) between January 2004 and April 2005. All participants lived in the areas of Montreal, Laval, and Sherbrooke in the Province of Quebec, Canada. After recruitment, they have been followed for 3 years with one clinical follow-up assessment each year (i.e.; 4 data collection time). A previous analysis performed on the NuAge study database has shown a significant decline of physical and cognitive performances with time (respectively an average of 10% and 2%), participants with lower physical performance showing lower cognitive performance.

Individuals with MCR
The diagnosis of MCR syndrome will be made following the criteria of Verghese et al. 5: a combination of subjective cognitive complaint, in particular of memory complaint, with the presence of an objective slow gait and the absence of dementia or mobility disability. MCR syndrome will be defined at baseline assessment and each year of follow-up period. Slow gait speed will be defined as gait speed that is one standard deviation (SD) or more below age-and sex-appropriate mean values established in the present cohort like in previous studies. The mean value and SD of female and male will be determined separately. Gait speed was determined from the 3-meter walking test using the best time of the two trials recorded and expressed as meters per second.
Other: Data Collection
The NuAge study has been designed to investigate nutrition as a determinant of successful aging in older men and women in Quebec. This study is based on a population-based observational cohort design that initially recruited healthy community-dwellers with age ranged from 67 to 82 years (51.8% women) between January 2004 and April 2005. All participants lived in the areas of Montreal, Laval, and Sherbrooke in the Province of Quebec, Canada. After recruitment, they have been followed for 3 years with one clinical follow-up assessment each year (i.e.; 4 data collection time). A previous analysis performed on the NuAge study database has shown a significant decline of physical and cognitive performances with time (respectively an average of 10% and 2%), participants with lower physical performance showing lower cognitive performance.




Primary Outcome Measures :
  1. Cognitive impairment [ Time Frame: 1 day ]
    Cognitive status has been measured using the Modified Mini-Mental State (3MS)17 in the NuAge study. The 3MS test has a score range of 1-100. Baseline value and change over the three years of follow-up will be used. Cognitive impairment will be considered when 3MS score < 79.

  2. Cognitive decline [ Time Frame: 1 day ]
    From T2 to T4 annual variation of 3MS score expressed in percentage between T1-T2, T2-T3 and T3-T4 will be calculated using the formula: ((3MS Tn+1 - 3MS Tn+1) / ((3MS Tn+1 + 3MS Tn+1) / 2)) x 100.

  3. Incident dementia [ Time Frame: 1 day ]
    From T2 to T4, incident dementia will be considered if 3MS score is ≤79/100 and simplified instrumental activity daily living score is <4

  4. Physical functional impairment [ Time Frame: 1 day ]
    A sex-specific global measure of physical performance will be computed as the sum of scores in four tests: standing balance, walking speed (normal and fast), chair stands, and timed "Up & Go" according to a slightly modified method proposed by Guralnik and colleagues.18 The validity of this global measure has been previously reported in this population.19 Four levels of physical performance will be created for each of the five tests. A score from 1 (slowest) to 4 (fastest) is assigned according to the quartile of time needed to carry out the test. With the exception of standing balance, the lowest quartile indicates the best (shorter duration) score. The reverse is true with respect to standing balance. A score of 0 was assigned to those who could not do or did not complete the test because they felt unable to do so. Possible scores range from 0 (worst) to 20 (best).

  5. Physical functional Decline [ Time Frame: 1 day ]
    From T2 to T4 annual variation of Physical functional score expressed in percentage between T1-T2, T2-T3 and T3-T4 were calculated using the formula: ((score Tn+1 - score Tn+1) / ((score Tn+1 + score Tn+1) / 2)) x 100

  6. Falls [ Time Frame: 1 day ]
    number of falls

  7. Hospitalizations [ Time Frame: 1 day ]
    Number of hospitalization

  8. Mortality [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

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): NCT04240028


Locations
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Canada, Quebec
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
Investigators
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Principal Investigator: Olivier Beauchet, MD McGill University, Jewish General Hospital
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Responsible Party: Olivier Beauchet, Professor of Geriatrics, Holder of the Dr. Joseph Kaufmann Chair in Geriatric Medicine, Clinician Scientist, Director of Centre of Excellence on Longevity, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT04240028    
Other Study ID Numbers: 2020-2029
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes