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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001368
Receipt No. R000001637
Scientific Title Randomized prospective cognitive training study on elderly Japanese in Osaka 2
Date of disclosure of the study information 2009/03/01
Last modified on 2010/09/15

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Basic information
Public title Randomized prospective cognitive training study on elderly Japanese in Osaka 2
Acronym Southern Osaka Cognitive Training Study 2
Scientific Title Randomized prospective cognitive training study on elderly Japanese in Osaka 2
Scientific Title:Acronym Southern Osaka Cognitive Training Study 2
Region
Japan

Condition
Condition elderly person with cognitive impairment or normal cognition
Classification by specialty
Neurology Psychosomatic Internal Medicine Geriatrics
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The impacts on cognition by cognitive training (calculation and reading) or general occupational therapy (paper craft and painting) will be examined.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ADAS-J cog (Alzheimer Disease Assessment Scale-Japan cognitive subscale)
Key secondary outcomes MMSE (Mini-Mental State Examination)
FAB (Frontal Assessment Battery at bedside)
MOSES (Multidimentional Observation Scale for Elderly Subjects)
FIM (functional independence measure)
VAS (visual analogue scale for satisfaction)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive training (6 months) following by general occupational therapy (6 months).
Intervention patients receive two session per week. Each session is 30 min.
Interventions/Control_2 General occupational therapy (6 months) followed by cognitive training (6 months).
Intervention patients receive two session per week. Each session is 30 min.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Elderly persons who receive day care more than twice a week and be able to take part in calculation, reading, painting and paper craft will be recruited.
Key exclusion criteria MMSE score is less than 11.
Phisical disorder and psychiatric disorder that influence cognitive function (dementia and mood disorder are excluded).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi TAKEDA
Organization Osaka University Graduate School of Medicine
Division name Dept Psychiatry
Zip code
Address Yamada-oka 2-2 D3 Suita-shi Osaka 565-0871 JAPAN
TEL 06-6879-3051
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi MORIHARA
Organization Osaka University Graduate School of Medicine
Division name Dept Psychiatry
Zip code
Address
TEL
Homepage URL
Email moriha@psy.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Dept Psychiatry
Institute
Department

Funding Source
Organization Osaka Prefectural Government
Organization
Division
Category of Funding Organization
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
2009 Year 03 Month 01 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 No longer recruiting
Date of protocol fixation
2008 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We make stratified randomization by the presence of dementia (Alzheimer type dementia and cerebrovascular dementia) for the subgroup analysis.
The intervention is exactly same as "Randomized prospective Cognitive Training study on elderly Japanese in Osaka" (UMIN000000836).
Both studies are analyzed together, too.

Management information
Registered date
2008 Year 09 Month 10 Day
Last modified on
2010 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001637

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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