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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name