Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorThe Opole University of Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Community dwelling elderly individuals over the age of 65 years who get around by themselves.

Disqualifiers

Institutionalization

Inability to move around

Terminal diseases with an anticipated survival of less than 1 year.

Trial population

The study group will comprise community dwelling elderly individuals over the age of 65 years who get around by themselves.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,093 Participants
are grouped into 1 trial group
Group A: Elderly people over the age of 65 years

Trial outcomes

Primary outcomes

1

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.

Time frame
At the study entry during the first examination.
2

Determinants for the development of different types of frailty in a prospective observation

Determinants of frailty developing during the study period will be identified.

Time frame
Through the study completion, an average of 5 years.

Secondary outcomes

1

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.

Time frame
Through the study completion, an average of 5 years.
2

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.

Time frame
Through the study completion, an average of 5 years.
3

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.

Time frame
Through the study completion, an average of 5 years.
4

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.

Time frame
Through the study completion, an average of 5 years.

Other outcomes

Sponsors and contacts

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