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Application of Frailty Prevention Care Management Program of Community Elderly Adults

Primary Purpose

Frailty

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
FPCMP-Old Age
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frailty focused on measuring elderly adults, frailty prevention care management programs

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Community elders over 60 years old; able to communicate in Mandarin and Taiwanese and voluntarily participate in this course Exclusion Criteria: Those who suffer from severe chronic diseases (such as heart disease, end-stage kidney disease, cancer) or severe illness, etc., and are unable to exercise Those who have severe visual and hearing impairments or use assistive devices without communication barriers Suffering from severe bone and joint diseases (for example: severe osteoporosis, severe knee or shoulder joint degeneration) Arrhythmia that requires drug treatment or a cardiac pacemaker Those with severe cognitive impairment.

Sites / Locations

  • Taiwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FPCMP-Old Age group

usual group

Arm Description

The program mainly refers to Ha and Park (2020), and extends the development of the 12-week FPCMP-Old Age program, which combines sports and health integrated nursing management courses (nutrition, psychosocial, drug and other health management activities). Twice a week, 2 hours each time, 12 weeks, a total of 24 times, the execution period is scheduled to be from July to the end of September.

Participate in the original health promotion activities of the community group

Outcomes

Primary Outcome Measures

The Taiwanese version of Tilburg frailty indicator(TFI-T)
This scale was translated by the researchers and other teams from The Taiwanese version of Tilburg frailty indicator (TFI-T) developed by Gobbens and other scholars in 2010. It is divided into three parts, with a total of 15 items. The first part measures physical frailty (score range 0 -8 points), including: Unexpected weight loss, physical fitness, difficulty walking, balance, visual problems, hearing problems, hand strength, and physical fatigue. The second part is mental frailty (score range 0-4 points), including: cognition, depressive symptoms, anxiety and coping ability. The third part is social-level frailty (score range 0-3 points), including: living alone, social relationship and social support, etc., with 0-1 points for each question, and a total score of 15 points.
Chronic Disease and Health Problems Scale
The research tools refer to the "Severity of Chronic Diseases and Health Problems" edited by Pan Baoxia (2012). There are 21 chronic diseases and health problems scales in total. Respondents are asked to self-evaluate their chronic diseases and The number of symptoms of health problems, and explore the severity of chronic diseases and health problems that interfere with daily life. The scoring method for the severity of interference is 0 points for "no inconvenience", 1 point for "slight inconvenience", and 2 points for "slight inconvenience". The total score ranges from 0 to 42 points. Chronic diseases or health problems affect life more seriously.
Health Function
Refer to the Senior Fitness Test (SFT) recommended by the Sports Administration of the Ministry of Education in 2016, which refers to the ability of subjects to perform daily activities independently without excessive fatigue and safety concerns. The muscles of the elderly are tested separately. Strength, Muscular Endurance, Cardiorespiratory Endurance, Body Flexibility, Balance, Coordination, Reaction Time and Body Composition
Nutritional Assessment
The Mini Nutritional Assessment-Short Form (MNA-SF) is used for assessment. MNA-SF has 6 questions, the minimum score range is 0-2 points, the maximum score range is 0-3 points, and the total score 14 points, if the score ≥ 11 points, it means that the nutritional status of the subject is within the acceptable range, 8-11 points: there is a risk of malnutrition, 0-7 points: malnutrition.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
May 29, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05883423
Brief Title
Application of Frailty Prevention Care Management Program of Community Elderly Adults
Official Title
Application of Frailty Prevention Care Management Program on Frailty and Health Function of Community Elderly Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community. The elderly in the long-term care community bases in the central and southern regions were selected as the object of acceptance. The study design is divided into two years(Two phases) study, the first phase is to develop a 12-week frailty prevention care management plan (FPCMP-Old Age). The second stage is to introduce FPCMP-Old Age to carry out a pilot study in the south-central community. A total of 70 cases were accepted in the experimental group and the control group. This study was divided into two groups, which were grouped by convenient sampling. The experimental group underwent the FPCMP-Old Ag program; the control group only maintained the original site to delay disability and dementia activities. In this study, pre-intervention, post-intervention, and four-week follow-up were conducted, and three questionnaires were evaluated. Each time it was estimated to spend 30 minutes for each answer, the activity lasted for 12 weeks. The execution period this time is from January 1, 2023 to December 30, 2024, but the time for accepting cases is from June 1, 2023 to December 31, 2023. There are four research tools in this study, namely: demographic variables, chronic disease and health problem scale, frailty detection tool (TFI-T), health function (refer to the 2016 recommendation of the Ministry of Education and Sports Administration for the fitness of the elderly group Test items, testing the subject's body composition, upper and lower limb muscle strength, upper and lower limb flexibility, cardiorespiratory endurance, dynamic and static balance) and nutritional status (mini nutritional assessment) and other tools. Data were collected in triplicate, and generalized estimating equations were used to analyze whether there were differences in interaction effects between groups, within groups, and time. The Frailty Prevention Care Management Program (FPCMP-Old Age) can help community-based adults and older adults reduce frailty and improve health function.
Detailed Description
Background :The elderly are a high-risk group for developing frailty symptoms. The prevalence of frailty ranges from 16% for those over 65 years of age to 52% for those over 85 years of age, and it increases proportionally with age. Frailty is not a disease. It represents the cumulative functional degeneration of various systems. It is a sub-healthy state or a stage before disability. Some elderly people have different degrees of frailty. In mild cases, there may be no clinical symptoms. Interference part of life; more severe cases may lead to disability or disease. Objective:This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community. Methods:The elderly in the long-term care community bases in the central and southern regions were selected as the object of acceptance. The study design is divided into two years(Two phases) study, the first phase is to develop a 12-week frailty prevention care management plan (FPCMP-Old Age). The second stage is to introduce FPCMP-Old Age to carry out a pilot study in the south-central community. A total of 70 cases were accepted in the experimental group and the control group. This study was divided into two groups, which were grouped by convenient sampling. The experimental group underwent the FPCMP-Old Ag program; the control group only maintained the original site to delay disability and dementia activities. In this study, pre-intervention, post-intervention, and four-week follow-up were conducted, and three questionnaires were evaluated. Each time it was estimated to spend 30 minutes for each answer, the activity lasted for 12 weeks. The execution period this time is from January 1, 2023 to December 30, 2024, but the time for accepting cases is from June 1, 2023 to December 31, 2023. There are four research tools in this study, namely: demographic variables, chronic disease and health problem scale, frailty detection tool (TFI-T), health function (refer to the 2016 recommendation of the Ministry of Education and Sports Administration for the fitness of the elderly group Test items, testing the subject's body composition, upper and lower limb muscle strength, upper and lower limb flexibility, cardiorespiratory endurance, dynamic and static balance) and nutritional status (mini nutritional assessment) and other tools. Data were collected in triplicate, and generalized estimating equations were used to analyze whether there were differences in interaction effects between groups, within groups, and time. Conclusions/practical application: The Frailty Prevention Care Management Program (FPCMP-Old Age) can help community-based adults and older adults reduce frailty and improve health function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
elderly adults, frailty prevention care management programs

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FPCMP-Old Age group
Arm Type
Experimental
Arm Description
The program mainly refers to Ha and Park (2020), and extends the development of the 12-week FPCMP-Old Age program, which combines sports and health integrated nursing management courses (nutrition, psychosocial, drug and other health management activities). Twice a week, 2 hours each time, 12 weeks, a total of 24 times, the execution period is scheduled to be from July to the end of September.
Arm Title
usual group
Arm Type
No Intervention
Arm Description
Participate in the original health promotion activities of the community group
Intervention Type
Other
Intervention Name(s)
FPCMP-Old Age
Intervention Description
Exercise program:The main purpose of the exercise program is to improve cardiorespiratory endurance, upper and lower limb muscle strength and endurance, body flexibility, sense of balance and coordination. The exercise program is carried out with a suspension training system, which can improve core muscle strength, improve physical fitness, activate more core and stabilizing muscle groups, increase joint stability, and strengthen ligaments. Health integrated nursing management courses (nutrition, psychosocial, drug and other health management activities involved)
Primary Outcome Measure Information:
Title
The Taiwanese version of Tilburg frailty indicator(TFI-T)
Description
This scale was translated by the researchers and other teams from The Taiwanese version of Tilburg frailty indicator (TFI-T) developed by Gobbens and other scholars in 2010. It is divided into three parts, with a total of 15 items. The first part measures physical frailty (score range 0 -8 points), including: Unexpected weight loss, physical fitness, difficulty walking, balance, visual problems, hearing problems, hand strength, and physical fatigue. The second part is mental frailty (score range 0-4 points), including: cognition, depressive symptoms, anxiety and coping ability. The third part is social-level frailty (score range 0-3 points), including: living alone, social relationship and social support, etc., with 0-1 points for each question, and a total score of 15 points.
Time Frame
It takes 5 minutes to fill out the questionnaire
Title
Chronic Disease and Health Problems Scale
Description
The research tools refer to the "Severity of Chronic Diseases and Health Problems" edited by Pan Baoxia (2012). There are 21 chronic diseases and health problems scales in total. Respondents are asked to self-evaluate their chronic diseases and The number of symptoms of health problems, and explore the severity of chronic diseases and health problems that interfere with daily life. The scoring method for the severity of interference is 0 points for "no inconvenience", 1 point for "slight inconvenience", and 2 points for "slight inconvenience". The total score ranges from 0 to 42 points. Chronic diseases or health problems affect life more seriously.
Time Frame
It takes 5 minutes to fill out the questionnaire
Title
Health Function
Description
Refer to the Senior Fitness Test (SFT) recommended by the Sports Administration of the Ministry of Education in 2016, which refers to the ability of subjects to perform daily activities independently without excessive fatigue and safety concerns. The muscles of the elderly are tested separately. Strength, Muscular Endurance, Cardiorespiratory Endurance, Body Flexibility, Balance, Coordination, Reaction Time and Body Composition
Time Frame
It takes 15 minutes to test health function
Title
Nutritional Assessment
Description
The Mini Nutritional Assessment-Short Form (MNA-SF) is used for assessment. MNA-SF has 6 questions, the minimum score range is 0-2 points, the maximum score range is 0-3 points, and the total score 14 points, if the score ≥ 11 points, it means that the nutritional status of the subject is within the acceptable range, 8-11 points: there is a risk of malnutrition, 0-7 points: malnutrition.
Time Frame
It takes 5 minutes to fill out the questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Community elders over 60 years old; able to communicate in Mandarin and Taiwanese and voluntarily participate in this course Exclusion Criteria: Those who suffer from severe chronic diseases (such as heart disease, end-stage kidney disease, cancer) or severe illness, etc., and are unable to exercise Those who have severe visual and hearing impairments or use assistive devices without communication barriers Suffering from severe bone and joint diseases (for example: severe osteoporosis, severe knee or shoulder joint degeneration) Arrhythmia that requires drug treatment or a cardiac pacemaker Those with severe cognitive impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Hui Lin, PhD
Phone
+886-912748610
Email
clh9031@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hui Lin, PhD
Organizational Affiliation
Chang Gung Medical Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Taiwan
City
Chiayi City
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Hui Lin, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26950344
Citation
Gulmez I. Effects of Angle Variations in Suspension Push-up Exercise. J Strength Cond Res. 2017 Apr;31(4):1017-1023. doi: 10.1519/JSC.0000000000001401.
Results Reference
result
PubMed Identifier
32933119
Citation
Ha J, Park YH. Effects of a Person-Centered Nursing Intervention for Frailty among Prefrail Community-Dwelling Older Adults. Int J Environ Res Public Health. 2020 Sep 13;17(18):6660. doi: 10.3390/ijerph17186660.
Results Reference
result
PubMed Identifier
16913163
Citation
McDermott AY, Mernitz H. Exercise and older patients: prescribing guidelines. Am Fam Physician. 2006 Aug 1;74(3):437-44.
Results Reference
result

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Application of Frailty Prevention Care Management Program of Community Elderly Adults

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