NCT04518423 Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People
| NCT ID | NCT04518423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Opole University of Technology |
| Condition | Frailty |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,093 participants |
| Start Date | 2017-09-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,093 participants in total. It began in 2017-09-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jerzy Sacha, MD, PhD
PRINCIPAL INVESTIGATOR
Faculty of Physical Education and Physiotherapy, Opole University of Technology
Frequently Asked Questions
Who can join the NCT04518423 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04518423 currently recruiting?
Yes, NCT04518423 is actively recruiting participants. Contact the research team at j.sacha@po.edu.pl for enrollment information.
Where is the NCT04518423 trial being conducted?
This trial is being conducted at Opole, Poland.
Who is sponsoring the NCT04518423 clinical trial?
NCT04518423 is sponsored by The Opole University of Technology. The principal investigator is Jerzy Sacha, MD, PhD at Faculty of Physical Education and Physiotherapy, Opole University of Technology. The trial plans to enroll 1,093 participants.