UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001368 |
|---|---|
| Receipt number | 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 10:32:06 |
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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
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
moriha@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Dept Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001637
