Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547593
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A Multifaceted Nutrition Intervention for Frailty in the Community Elderly
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multifaceted Nutrition Intervention for Frailty in the Community Elderly a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With worlds older population is rapidly increasing Chinas population aging process is also accelerating Studies have shown that persistent frailty can increase the incidence of negative events in the elderly However research on elderly frailty in China is still in its early stages and existing research in China mainly focuses on the definition of frailty evaluation tools for frailty and cross-sectional surveys of small populations There is currently limited research on interventions
The MultIfaceted NUtrition inTErvention for Frailty minute trial is a randomized controlled trial to explore the trajectory characteristics and influencing factors of frailty in the community the impact of nutritional interventions on the developmental trajectory of frailty in the elderly in the community and the management model and appropriate technology for the sustainable intervention of frailty in the elderly based on the community
A total of 315 frail older adults will be recruited from Beijing After the screening period the compliant participants will be randomized to the control group the nutrition intervention group with the nutrition intervention alone or the combined nutrition intervention group with combining exercise and nutrition on a 111 ratio for 3 months The primary outcome is the change in SPPB from the baseline to the end of the study The change in SPPB as a primary outcome and frailty status demographic information health status nutrition assessment comprehensive geriatric assessment status quality of life intrinsic capacity and mental elasticity as secondary outcomes will be measured using validated questionnaires and clinical examinations
This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice Signed informed consent will be obtained from all participants The trial has been approved by the Peking University Institutional Review Board approval number IRB00001052-23178 The results will be disseminated through academic conferences and publications in international peer-reviewed journals
The MultIfaceted NUtrition inTErvention for Frailty minute trial is a randomized controlled trial to explore the trajectory characteristics and influencing factors of frailty in the community the impact of nutritional interventions on the developmental trajectory of frailty in the elderly in the community and the management model and appropriate technology for the sustainable intervention of frailty in the elderly based on the community
A total of 315 frail older adults will be recruited from Beijing After the screening period the compliant participants will be randomized to the control group the nutrition intervention group with the nutrition intervention alone or the combined nutrition intervention group with combining exercise and nutrition on a 111 ratio for 3 months The primary outcome is the change in SPPB from the baseline to the end of the study The change in SPPB as a primary outcome and frailty status demographic information health status nutrition assessment comprehensive geriatric assessment status quality of life intrinsic capacity and mental elasticity as secondary outcomes will be measured using validated questionnaires and clinical examinations
This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice Signed informed consent will be obtained from all participants The trial has been approved by the Peking University Institutional Review Board approval number IRB00001052-23178 The results will be disseminated through academic conferences and publications in international peer-reviewed journals
Detailed Description:
The global elderly population is rapidly increasing with the 65-and-over age group being the fastest growing Currently about 9 of the worlds population is over 65 and this proportion is projected to reach 16 by 2050 The silvering of Chinas population continues its steady march By the end of 2023 the population aged 60 and above is 29697 million accounting for 211 of the national population of which 21676 million are aged 65 and above accounting for 154 of the national population As Chinas population continues to age the silver tsunami shows no signs of abating By 2030 it is estimated that the number of elderly individuals aged 65 and above will have surged to approximately 240 million And by 2050 the ranks of octogenarians and above are projected to reach a staggering 100 million The overall health status of Chinas elderly population is a cause for concern More than 80 of individuals aged 65 and above suffer from at least one chronic disease and by the age of 75 this number increases to at least three Approximately 44 million elderly citizens are either partially or fully disabled casting a long shadow over their own lives placing a significant burden on their families and society The health of Chinas elderly has become a pressing public health issue that demands the attention of the entire nation Frailty is a geriatric syndrome characterized by an increased vulnerability to stressors It is a state of diminished physiological reserve and impaired function across multiple organ systems leading to increased dependency and mortality Epidemiological data suggest that the prevalence of frailty in the elderly population ranges from approximately 49 to 273 Among community-dwelling elderly individuals the prevalence is estimated to be between 69 and 149 The incidence of frailty increases with advancing age with over 25 of individuals aged 85 and older experiencing this debilitating condition Research has painted a sobering picture of the consequences of persistent frailty in the elderly population It has been shown to increase the risk of a cascade of negative events including falls disability delirium hospitalization and even premature mortality The risk of morbidity and mortality escalates significantly with a 68 increase in all-cause mortality for every 01-unit increase in the frailty index HR168 95 CI 166-171 Frailty also places a heavy burden on caregivers and healthcare systems straining resources and exacerbating the challenges of caring for an aging population Furthermore frail elderly individuals are particularly vulnerable to precipitous declines in health even from minor stressors such as infections new medications falls constipation or urinary retention These events can trigger a downward spiral leading to hospitalization disability and even death severely compromising the quality of life for elderly individuals and placing a greater demand on healthcare services In the global tapestry of frailty research interventions have largely focused on isolated threads such as exercise regimens nutritional counseling risk factor modification and comprehensive care However the intricate web of frailty demands a more holistic approach one that weaves together these diverse strands There is a notable lack of research investigating comprehensive intervention measures It is of utmost importance to conduct community-based research to explore a comprehensive nutritional intervention model for frailty that is tailored to the unique characteristics of the Chinese population scientifically sound and sustainable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None