Aging Clinical Trial
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
Frailty syndrome (i.e. 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.
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 B.V., 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
concordance/discordance between physical and multidimensional frailty.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Completed |
NCT05293730 -
Trial of the Impact of the Electronic Frailty Integrated With Social Needs
|
N/A | |
Recruiting |
NCT03932162 -
Gene Expression Changes In Young and Geriatric Skin
|
Early Phase 1 | |
Completed |
NCT04064528 -
Effects of Age on Amino Acid Delivery to Tendon
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT06029920 -
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT05543980 -
Leg Heat Therapy in Elderly Individuals
|
Phase 2 | |
Recruiting |
NCT05566938 -
Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Not yet recruiting |
NCT06071130 -
Emotion, Aging, and Decision Making
|
N/A | |
Enrolling by invitation |
NCT04641663 -
Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)
|
N/A | |
Completed |
NCT04088006 -
The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity
|
N/A | |
Completed |
NCT03695081 -
Patient Pathway Pharmacist - Optimal Drug-related Care
|
N/A | |
Recruiting |
NCT05424263 -
Acetate and Age-associated Arterial Dysfunction
|
Phase 2 | |
Completed |
NCT05601713 -
Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling
|
N/A | |
Completed |
NCT04551339 -
Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19
|
N/A | |
Recruiting |
NCT04997577 -
Speech Perception and High Cognitive Demand
|
N/A | |
Completed |
NCT05922475 -
Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training
|
N/A | |
Completed |
NCT04015479 -
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults
|
N/A |