UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043566 |
|---|---|
| Receipt number | R000049753 |
| Scientific Title | Feasibility study of frailty prevention program using NCGG-HEPOP - a pilot study - |
| Date of disclosure of the study information | 2021/03/09 |
| Last modified on | 2025/09/02 15:46:25 |
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Basic information
Public title
A pilot study of frailty prevention program during the COVID-19 pandemic
Acronym
A pilot study of frailty prevention program during the COVID-19 pandemic
Scientific Title
Feasibility study of frailty prevention program using NCGG-HEPOP - a pilot study -
Scientific Title:Acronym
Feasibility study of frailty prevention program using NCGG-HEPOP - a pilot study -
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility of the frailty prevention program
Basic objectives2
Others
Basic objectives -Others
feasibility, safety, efficacy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Feasibility: Implementation rate of the elderly and the number of support activities implemented by volunteer staff
Key secondary outcomes
Change of response to Kihon Check List, EQ5D, grip strength, five times sit-to-stand test, calf circumference, physical activity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
For volunteer
Volunteers are given lectures on how to intervene and feedback for elderlies. They hold a meeting before, during, and after the intervention.
For elderlies
Elderlies choose appropriate exercise packages us ing the flowchart. They are expected to exercise ev ery day and record their activities and report them to the volunteers once a week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Comunity-dwelling elderly who participate in the long-term care prevention program and volunteer staff providing written informed consent
Key exclusion criteria
Those who have cognitive decline and difficulty in completing the program, those who have physical functional decline and a high risk of fall, or those the researchers consider inappropriate.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masayo |
| Middle name | |
| Last name | Kojima |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Frailty Research Center for Gerontology and Social Science
Zip code
474-8511
Address
7-430 Morioka Obu Aichi 474-8511
TEL
0562-46-2311
masayok@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Mikako |
| Middle name | Kojima |
| Last name | Yasuoka |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Frailty Research Center for Gerontology and Social Science
Zip code
474-8511
Address
7-430 Morioka Obu Aichi 474-8511
TEL
0562-46-2311
Homepage URL
yasuoka@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka Obu Aichi
Tel
0562-46-2311
yaday@ncgg.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
https://doi.org/10.24802/tpha.2023-02
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/1660-4601/19/11/6609
Number of participants that the trial has enrolled
65
Results
This study was an intervention trial that examined the feasibility of a three-month home-based exercise program aimed at preventing frailty during the COVID-19 pandemic. A total of 69 older women from four Kayoi-no-ba community groups participated, with a completion rate of 91.3% and an exercise adherence rate of 86.5%. The five times sit-to-stand test showed significant improvement, providing foundational data for designing a future randomized controlled trial.
Results date posted
| 2025 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study aimed to examine the feasibility of a three-month home-based exercise program designed to prevent the progression of frailty during the COVID-19 pandemic. Four groups of Kayoi-no-ba, community salons for frailty prevention, were recruited, and a total of 69 community-dwelling older women who had participated in one of these groups during a preliminary study were enrolled for follow-up.
Participant flow
The intervention program was developed based on the 5A approach. Focus group discussions were conducted with volunteer leaders from each community group. A 10-minute daily home-based exercise routine was implemented by adapting the Home Exercise Program for Older People from the National Center for Geriatrics and Gerontology.
Adverse events
None
Outcome measures
Feasibility outcomes showed that 91.3% of participants completed the intervention program, with an exercise adherence rate of 86.5% during the intervention period. As a health-related outcome, the five times sit-to-stand test demonstrated significant improvement after the intervention. These results suggest that the program is likely feasible, given the high completion and adherence rates. Furthermore, the observed improvement in the sit-to-stand test indicates potential benefits for frailty prevention. This study has provided essential data for planning a future cluster randomized controlled trial.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049753
