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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032039
Receipt No. R000036000
Scientific Title Effects of a dementia prevention program in communities with few social resource
Date of disclosure of the study information 2018/04/09
Last modified on 2018/03/31

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Basic information
Public title Effects of a dementia prevention program in communities with few social resource
Acronym Effects of a dementia prevention program in communities
Scientific Title Effects of a dementia prevention program in communities with few social resource
Scientific Title:Acronym Effects of a dementia prevention program in communities
Region
Japan

Condition
Condition well elderly and mild cognitive impairments
Classification by specialty
Neurology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to discuss effects of a dementia prevention program in communities with few social resource regards with a cognitive function, life style, physical fuctions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes D-CAT (1 week and 8 week)
5m walking speed (1 week and 8 week)

Standing time on one leg (1 week and 8 week)
life style change (8week)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 demenntia prevention program (study on dementia prevention, group activity, once a week) + exercise (onece a week)
Interventions/Control_2 exercise (onece a week)
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 eldely at community salons
Key exclusion criteria severe cognitive dysfunction and walking dysfuction
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nishida Seiji
Organization Prefectural University of Hiroshima
Division name Department of Occupational therapy
Zip code
Address Hiroshima, Mihara-city, Gakuen-cho, 1-1
TEL 0848-60-1275
Email s-nisida@pu-hiroshima.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tabata Tatsuya
Organization Prefectural University of Hiroshima
Division name Graduate School of Comprehensive Scientific Research
Zip code
Address Hiroshima, Mihara-city, Gakuen-cho, 1-1
TEL 090-4693-1232
Homepage URL
Email taba.t.716@gmail.com

Sponsor
Institute Prefectural University of Hiroshima
Institute
Department

Funding Source
Organization Prefectural University of Hiroshima
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
Address
Tel
Email

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
2018 Year 04 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 31 Day
Last modified on
2018 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036000

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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