Aging Clinical Trial
— FRAILPOLOfficial 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
NCT number | NCT04518423 |
Other study ID # | FRAILPOL |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2, 2017 |
Est. completion date | December 2026 |
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.
Status | Recruiting |
Enrollment | 1093 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Community dwelling elderly individuals over the age of 65 years who get around by themselves. Exclusion Criteria: - Institutionalization - Inability to move around - Terminal diseases with an anticipated survival of less than 1 year. |
Country | Name | City | State |
---|---|---|---|
Poland | Faculty of Physical Education and Physiotherapy, Opole University of Technology | Opole |
Lead Sponsor | Collaborator |
---|---|
The Opole University of Technology |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk factors associated with multidimensional and physical frailty and pre-frailty in community dwelling elderly people over the age of 65 years. | Risk factors associated with the existing frailty at the study entry will be identified. | At the study entry during the first examination. | |
Primary | Determinants for the development of different types of frailty in a prospective observation | Determinants of frailty developing during the study period will be identified. | Through the study completion, an average of 5 years. | |
Secondary | The impact of various modes of frailty and other clinical factors on the elderly people mortality. | Frailty impact on mortality in elderly people will be investigated. | Through the study completion, an average of 5 years. | |
Secondary | Predictors for frailty development, disability or mortality as a composite endpoint. | Determinants of frailty development, disability or mortality as a composite endpoint will be investigated. | Through the study completion, an average of 5 years. | |
Secondary | The rate and determinants of a frailty status transition to a more robust status. | The rate and determinants of the recovery from different statuses of frailty will be investigated. | Through the study completion, an average of 5 years. | |
Secondary | The prevalence of multidimensional frailty, and physical frailty and pre-frailty in elderly people in Polish community. | The prevalence of different types of frailty in Polish community will be investigated. | Through the study completion, an average of 5 years. | |
Secondary | The concordance and discordance between physical and multidimensional frailty. | The concordance and discordance between different types of frailty will be investigated. | Through the study completion, an average of 5 years. |
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