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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036340
Receipt No. R000041407
Scientific Title The effect of cognitive issues on cognitive function and life function of the elderly in the community
Date of disclosure of the study information 2019/04/25
Last modified on 2019/03/29

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Basic information
Public title The effect of cognitive issues on cognitive function and life function of the elderly in the community
Acronym The effect of cognitive issues on cognitive function and life function of the elderly in the community
Scientific Title The effect of cognitive issues on cognitive function and life function of the elderly in the community
Scientific Title:Acronym The effect of cognitive issues on cognitive function and life function of the elderly in the community
Region
Japan

Condition
Condition Community-dwelling Elderly
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of cognitive problems created for the maintenance and improvement of cognitive function on cognitive function and life function of the elderly in healthy regions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Montreal Cognitive Assessment-Japan;MoCA-J
Before and after 12 weeks of assignment
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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 We conducted 10-15 minutes a day for 12 weeks. Check the implementation status of the issue every week.
Interventions/Control_2 Control:Only the front and back evaluation is carried out.
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 An elderly person who is 65 years of age or older who is independent of ADL in indoor and outdoor
Key exclusion criteria A person who has a diagnosis of dementia and is taking medication
Persons participating in other intervention studies
Those who have received the required care certification
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Kanai
Organization Toyohashi SOZO University Graduate School
Division name Graduate School of Health Sciences
Zip code 440-8511
Address 20-1,Matsusita Ushikawa-cho,Toyohashi,Aichi
TEL 05020172276
Email kanai@sozo.ac.jp

Public contact
Name of contact person
1st name Rie
Middle name
Last name Nakajima
Organization Toyohashi SOZO University Graduate School
Division name Graduate School of Health Sciences
Zip code 440-8511
Address 20-1,Matsusita Ushikawa-cho,Toyohashi,Aichi
TEL 05020172273
Homepage URL
Email ri-nakajima@sozo.ac.jp

Sponsor
Institute Toyohashi SOZO University Graduate School
Institute
Department

Funding Source
Organization Toyohashi SOZO University Graduate School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toyohashi SOZO University IRB
Address 20-1,Matsusita Ushikawa-cho,Toyohashi,Aichi
Tel 0532542111
Email kanai@sozo.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
2019 Year 04 Month 25 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
2018 Year 09 Month 15 Day
Date of IRB
2018 Year 10 Month 25 Day
Anticipated trial start date
2019 Year 04 Month 25 Day
Last follow-up date
2019 Year 09 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
2019 Year 03 Month 29 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041407

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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