UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046276 |
|---|---|
| Receipt number | R000051545 |
| Scientific Title | Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment. |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2021/12/04 00:08:07 |
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Basic information
Public title
Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment.
Acronym
Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment.
Scientific Title
Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment.
Scientific Title:Acronym
Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment.
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive score measured by eye-tracking-based cognitive assessment after three months intervention
Key secondary outcomes
Barthel Index after three months intervention
Dementia Behavior Disturbance Scale (DBD13) after three months intervention
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 |
Interventions/Control_1
Three-month intervention period
Motor-cognitive dual task trainig, 1-2 times per week
Interventions/Control_2
Three-month intervention period
No intervention
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People with mild coginitve impairment and at a risk of developing cognitive impairment.
Key exclusion criteria
People with severe hearing or visual impairment are excluded from the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shuko |
| Middle name | |
| Last name | Takeda |
Organization
Osaka university
Division name
Graduate school of medicine
Zip code
565-0871
Address
2-2 Yamada-oka, Suita
TEL
0662108351
takeda@cgt.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuko |
| Middle name | |
| Last name | Takeda |
Organization
Osaka university
Division name
Graduate school of medicine
Zip code
565-0871
Address
2-2 Yamada-oka, Suita
TEL
0662108351
Homepage URL
takeda@cgt.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
Solasto Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka university
Address
2-2 Yamada-oka, Suita
Tel
06-6210-8296
handai-nintei@hp-crc.med.osaka-u.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
| 2022 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 12 | Month | 04 | Day |
Last modified on
| 2021 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051545
