Cognitive-prefrailtyNCT04240028
The Cognitive-Prefrail Syndrome and Its Association With Adverse Health Outcomes
An observational study of Cognitive-prefrailty and Prefrailty, run by Jewish General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive-prefrailty, Prefrailty, Motoric Cognitive Risk Syndrome
- What is being tested?
- Data Collection
- How many people
- 1,741 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2020to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Be participants of the NuAge study who agreed to be part of the NuAge Database and Biobank for future research purposes
Who cannot join
- Missing data at baseline and follow-up assessments
- Participants' refusal to use their data for a purpose not identified during their recruitment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Cognitive-Prefrail Syndrome and Its Association With Adverse Health Outcomes: Results From the NuAge Observational Population-based Study
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.
Read the 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.
- Being tested
- Data Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data Collection | |
| 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. Receives: Other: Data Collection | |
| 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. Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment
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.
Measured: 1 day
Cognitive decline
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.
Measured: 1 day
Incident dementia
From T2 to T4, incident dementia will be considered if 3MS score is ≤79/100 and simplified instrumental activity daily living score is <4
Measured: 1 day
Physical functional impairment
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).
Measured: 1 day
Physical functional Decline
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
Measured: 1 day
Falls
number of falls
Measured: 1 day
Hospitalizations
Number of hospitalization
Measured: 1 day
Mortality
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start21 Jan 2020
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive-prefrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,741 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
- Investigators
- Olivier Beauchet, MD, Principal investigator, McGill University, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240028
- Sponsor's protocol ID
- 2020-2029
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive-Prefrail Syndrome and Its Association With Adverse Health Outcomes: Results From the NuAge Observational Population-based Study
- ClinicalTrials.gov ID
- NCT04240028
- Acronym / sponsor ID
- 2020-2029
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,741 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals with prefrailty | – | Other: Data CollectionThis 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. |
| Individuals with cognitive-prefrailty | – | Other: Data CollectionA 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. |
| Individuals with MCR | – | Other: Data CollectionThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Be participants of the NuAge study who agreed to be part of the NuAge Database and Biobank for future research purposes
Key exclusion criteria (2 listed)
- Missing data at baseline and follow-up assessments
- Participants' refusal to use their data for a purpose not identified during their recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionThe 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. | Other | Individuals with MCR, Individuals with cognitive-prefrailty, Individuals with prefrailty |
Primary outcome
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.
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.
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
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).
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
Falls
Time frame: 1 day
number of falls
Hospitalizations
Time frame: 1 day
Number of hospitalization
Mortality
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Beauchet, MD principal investigator
McGill University, Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive-prefrailty and Prefrailty, run by Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.