NCT05883423

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

May 10, 2023

Last Update Submit

May 29, 2023

Conditions

Keywords

elderly adultsfrailty prevention care management programs

Outcome Measures

Primary Outcomes (4)

  • 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.

    It takes 5 minutes to fill out the questionnaire

  • 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.

    It takes 5 minutes to fill out the questionnaire

  • 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

    It takes 15 minutes to test health function

  • 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.

    It takes 5 minutes to fill out the questionnaire

Study Arms (2)

FPCMP-Old Age group

EXPERIMENTAL

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.

Other: FPCMP-Old Age

usual group

NO INTERVENTION

Participate in the original health promotion activities of the community group

Interventions

1. 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. 2. Health integrated nursing management courses (nutrition, psychosocial, drug and other health management activities involved)

FPCMP-Old Age group

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community elders over 60 years old; able to communicate in Mandarin and Taiwanese and voluntarily participate in this course

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan

Chiayi City, Taiwan

Location

Related Publications (3)

  • 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.

  • 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.

  • McDermott AY, Mernitz H. Exercise and older patients: prescribing guidelines. Am Fam Physician. 2006 Aug 1;74(3):437-44.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chia-Hui Lin, PhD

    Chang Gung Medical Foundation

    STUDY DIRECTOR

Central Study Contacts

Chia-Hui Lin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD,RN,Associate Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 1, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations