跳至主要内容
临床试验/NCT04240028
NCT04240028进行中(未招募)不适用

The Cognitive-Prefrail Syndrome and Its Association With Adverse Health Outcomes: Results From the NuAge Observational Population-based Study

Jewish General Hospital1 个研究点 分布在 1 个国家目标入组 1,741 人开始时间: 2020年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,741
试验地点
1
主要终点
Incident dementia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Incident dementia

时间窗: 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

Mortality

时间窗: 1 day

Cognitive impairment

时间窗: 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.

Cognitive decline

时间窗: 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.

Physical functional impairment

时间窗: 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).

Physical functional Decline

时间窗: 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

Falls

时间窗: 1 day

number of falls

Hospitalizations

时间窗: 1 day

Number of hospitalization

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (1)

Loading locations...

相似试验