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

NCT04518423 | Recruiting

• 1 other identifier: FRAILPOL
• Study Type: observational
• Target: 1,093
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty; Frailty Syndrome; Frail Elderly Syndrome; Fragility; Aging; Aging Problems; Aging Disorder; Aging Well

Keywords

Frailty; Physical Frailty; Cognitive Frailty; Social Frailty; Multidimensional Frailty; Elderly; Aging; Frail Scale; Tilburg Frailty Indicator

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• The impact of various modes of frailty and other clinical factors on the elderly people mortality.

  Through the study completion, an average of 5 years.

• Predictors for frailty development, disability or mortality as a composite endpoint.

  Through the study completion, an average of 5 years.

• The rate and determinants of a frailty status transition to a more robust status.

  Through the study completion, an average of 5 years.

• The prevalence of multidimensional frailty, and physical frailty and pre-frailty in elderly people in Polish community.

  Through the study completion, an average of 5 years.

• The concordance and discordance between physical and multidimensional frailty.

  Through the study completion, an average of 5 years.

Study Arms (1)

Elderly people over the age of 65 years

The study group will comprise community dwelling elderly individuals over the age of 65 years who get around by themselves. The subjects will be followed up for 5 years to investigate the frailty and disability development, and survival.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Institutionalization
• Inability to move around
• Terminal diseases with an anticipated survival of less than 1 year.

Sponsors & Collaborators

• The Opole University of Technology: lead

Study Sites (1)

Faculty of Physical Education and Physiotherapy, Opole University of Technology

Opole, 45-758, Poland

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jerzy Sacha, MD, PhD

  Faculty of Physical Education and Physiotherapy, Opole University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerzy Sacha, MD, PhD

CONTACT

+48 600 273 616; j.sacha@po.edu.pl

Zbigniew Borysiuk, PhD

CONTACT

+48 77 449 82 50; z.borysiuk@po.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 19, 2020
• Study Start: September 2, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

PL (1)