UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017028 |
|---|---|
| Receipt number | R000019747 |
| Scientific Title | Effect of community activities by education of care prevention supporters exerting in health for frail elderly and supporters themselves and social capital index |
| Date of disclosure of the study information | 2015/04/06 |
| Last modified on | 2023/04/10 14:04:21 |
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Basic information
Public title
Effect of community activities by education of care prevention supporters exerting in health for frail elderly and supporters themselves and social capital index
Acronym
Effects of education of preventive care supporters on the social capital index in the community
Scientific Title
Effect of community activities by education of care prevention supporters exerting in health for frail elderly and supporters themselves and social capital index
Scientific Title:Acronym
Effects of education of preventive care supporters on the social capital index in the community
Region
| Japan |
Condition
Condition
Frail elderly
Classification by specialty
| Geriatrics | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Education and activities of preventive care supporters, and to clarify the impact on social capital intensity of the health state and regional in frail elderly and the supporters themselves.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Timed Up and Go Test
Key secondary outcomes
Social capital index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: The exercise carried by preventive care supporters
Interventions/Control_2
Control: Health education
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
Preventive care supporters: Healthy adults
Subjects in preventive care class: Person who has been determined that the frail elderly in the basic checklist on preventive care subjects by the Ministry of Health, Labour and Welfare.
Key exclusion criteria
A person who has severe heart disease, high blood pressure, a moderate or severe cognitive dysfunction.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Faculty of health ascience
Zip code
6350832
Address
Umami-naka, Kitakatsuragi-gun, Koryo, Nara
TEL
0745-54-1601
k.takatori@kio.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Faculty of health science
Zip code
635-0832
Address
Umami-naka, Kitakatsuragi-gun, Koryo, Nara
TEL
0745-54-1601
Homepage URL
k.takatori@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2,Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
k.takatori@kio.ac.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
| 2015 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019747
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-16K01783/
Number of participants that the trial has enrolled
120
Results
As an effect of "mutual assistance," participants' leg strength and balance improved compared to those before participation (p<0.01). As a "self-help" effect, leg strength and flexibility improved between the start of the leadership program and 18 months later (p<0.01).
Results date posted
| 2023 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
To verify the objective effects of "mutual assistance" in resident-centered care prevention, we compared changes in participants' physical function and lifestyle function before and after participation in a resident-centered day-care center run by care prevention leaders trained in two municipalities that were able to collaborate with universities. To verify the objective effects of "self-help," the physical functions of the care prevention leaders themselves were evaluated over time from the start of the activities, and changes in their sense of efficacy toward the activities and their attitudes toward health were surveyed through questionnaires.We also examined individual-level social capital intensity (trust, reciprocity, and social activity) among participants in a day-care center where a care prevention leader was active, and compared it with that of participants in a day-care center in a community where no care prevention leader was active.
Participant flow
Sixty participants in care prevention classes held in the community and 60 care prevention leaders trained by the university were recruited for the study.
Adverse events
Non
Outcome measures
As the effect of "mutual assistance," the number of times to stand up for 30 seconds and the complex movement ability (Timed Up and Go) of the participants in the care prevention leader-operated group improved significantly compared with those before participation. As effects of "self-help,"significant improvements were observed in leg strength (number of 30-second stands) and flexibility at the start of the care prevention leader activity compared to 18 months after the activity. No significant differences were found in skeletal muscle mass (SMI: 6.4 at the start of activity, SMI,6.5 after activity) and body fat percentage (30.2% at the start of activity, 29.4% after activity).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 02 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019747
