Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04518423
Status:
RECRUITING
Last Update Posted:
2020-08-19
First Post:
2020-08-12
Brief Title:
Prevalence Determinants and Natural History of Frailty and Pre-frailty in Elderly People
Sponsor:
The Opole University of Technology
Organization:
The Opole University of Technology
Study Overview
Official Title:
Prevalence Determinants and Natural History of Frailty and Pre-frailty in People Over the Age of 65 Years in a Prospective 5-year Observation
Status:
RECRUITING
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRAILPOL
Brief Summary:
Frailty syndrome ie frailty is a geriatric syndrome which relies on the reduction of multisystem reserve capacity Frail people have a lower potential to respond to external stressors and various life incidents as well as they present a weak prognosis particularly in cardiovascular diseases Yet frailty is not only a set of physical deficits but it also concerns psychological and social dimensions of human functioning Hence an approach to frailty should be multidimensional because such a concept more adequately reflects a functional degradation in the elderly Frailty is usually associated with the impaired condition of circulatory system and therefore an identification of subclinical cardiovascular abnormalities is paramount in the frailty prevention and treatment Another potential mechanism which may predispose to frailty is a dysfunction of the autonomic nervous system This system plays a crucial role in the response to internal or external stressors such as diseases and activities of daily living An impairment of the autonomic nervous system function may maintain or accelerate the frailty process
In this scientific project a comprehensive echocardiography will investigate cardiac function with a particular attention to features which typically change with age like flow parameters and chambers sizes The activity of the autonomic nervous system will be explored with the analysis of heart rate blood pressure and respiratory signals The study participants will also undergo routine medical examination and a number of additional tests including assessment of cognitive function psychological condition nutrition status activities of daily living and risk of falls The study group will comprise community dwelling elderly individuals over the age of 65 years who get around by themselves After 2 years the participants will be re-examined for their frailty and independence status as well as their survival will be checked with the National Health Found electronic system The aim of this project is to seek for factors determining frailty and to explore the frailty impact on the elderly people survival Particular attention will be paid to the multidimensional frailty which is a new concept of the functional decline in the elderly In addition the prevalence of different modes of frailty in Polish community will be investigated The results of this research should help to establish preventative and therapeutic strategies against frailty
In this scientific project a comprehensive echocardiography will investigate cardiac function with a particular attention to features which typically change with age like flow parameters and chambers sizes The activity of the autonomic nervous system will be explored with the analysis of heart rate blood pressure and respiratory signals The study participants will also undergo routine medical examination and a number of additional tests including assessment of cognitive function psychological condition nutrition status activities of daily living and risk of falls The study group will comprise community dwelling elderly individuals over the age of 65 years who get around by themselves After 2 years the participants will be re-examined for their frailty and independence status as well as their survival will be checked with the National Health Found electronic system The aim of this project is to seek for factors determining frailty and to explore the frailty impact on the elderly people survival Particular attention will be paid to the multidimensional frailty which is a new concept of the functional decline in the elderly In addition the prevalence of different modes of frailty in Polish community will be investigated The results of this research should help to establish preventative and therapeutic strategies against frailty
Detailed Description:
Frailty is a geriatric syndrome which relies on the reduction of multisystem reserve capacity whereas pre-frailty is a condition predisposing and preceding the frailty state Frail people have a lower potential to respond to external stressors and various life incidents as well as they present a weak prognosis particularly in cardiovascular diseases However frailty is not only a set of physical deficits but it also concerns psychological and social dimensions of human functioning Hence an approach to frailty should be multidimensional because such a concept more adequately reflects a functional degradation in the elderly Frailty is usually associated with the impaired condition of circulatory system and therefore an identification of subclinical cardiovascular abnormalities which are associated with frailty is paramount in a context of frailty prevention and treatment In this study a comprehensive echocardiography will investigate cardiac function with a particular attention to features which typically change with age like flow and diastolic parameters as well as chambers sizes Specifically the impact of the impaired diastolic filling pattern on the frailty development will be thoroughly investigated Another potential mechanism which may predispose to frailty is a dysfunction of the autonomic nervous system ANS - especially its cardiac branch ANS plays a crucial role in the response to internal or external stressors such as diseases and activities of daily living and it plays a pivotal role in the homeostasis Since frail people present a progressive homeostatic dysregulation it is possible that the impairment in the cardiac ANS may maintain or accelerate the frailty process In the present study both tonic and reflex activities of the cardiac ANS will be explored with Finapres device Finapres Medical Systems BV Amsterdam the Netherlands which is a gold standard for non-invasive continuous blood pressure monitoring and also allows ECG and respiratory signals recording The study participants will also undergo routine medical examination standard 12-lead electrocardiography and measurements of body mass index and ankle-brachial index - the latter will reflect the degree of lower extremity arterial disease A cognitive function and a psychological condition will be evaluated with the Mini-Mental State Examination MMSE and the Geriatric Depression Scale respectively A nutrition status will be checked with the Mini Nutritional Assessment MNA The Activities of Daily Living ADL and Instrumental Activities of Daily Living IADL will be assessed with dedicated scales A risk of fall will be judged with the questionnaire concerning the falls history and by examining a postural stability on a force plate AccuSway AMTI Watertown MA USA The study group will comprise community dwelling elderly individuals over the age of 65 years who get around by themselves The exclusion criteria include institutionalization inability to move around and terminal diseases with an anticipated survival of less than 1 year After 2 and 5 years the participants will be re-examined for their frailty and independence status and in addition their life status will be checked with national identification numbers by using the National Health Found registration system Sample size calculation indicates that the minimum sample size to investigate frailty development should equal 994 subjects 1 margin of error and 95 confidence interval however assuming 10 loss in follow-up the final sample size is 1093 subjects
The primary endpoints of this study are i to identify risk factors associated with multidimensional and physical frailty and pre-frailty in community dwelling elderly people over the age of 65 years ii to find determinants for the development of different types of frailty in a prospective observation The secondary endpoints are i to explore the impact of various modes of frailty and other clinical factors on the elderly people mortality ii to identify predictors for frailty development disability or mortality as a composite endpoint iii to explore the rate and determinants of a frailty status transition to a more robust status iv to establish the prevalence of multidimensional frailty and physical frailty and pre-frailty in elderly people in Polish community v to determine a concordancediscordance between physical and multidimensional frailty
The primary endpoints of this study are i to identify risk factors associated with multidimensional and physical frailty and pre-frailty in community dwelling elderly people over the age of 65 years ii to find determinants for the development of different types of frailty in a prospective observation The secondary endpoints are i to explore the impact of various modes of frailty and other clinical factors on the elderly people mortality ii to identify predictors for frailty development disability or mortality as a composite endpoint iii to explore the rate and determinants of a frailty status transition to a more robust status iv to establish the prevalence of multidimensional frailty and physical frailty and pre-frailty in elderly people in Polish community v to determine a concordancediscordance between physical and multidimensional frailty
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None