UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025484 |
|---|---|
| Receipt number | R000028956 |
| Scientific Title | Verification of the effect to prevent dementia of dual-task and N-back task by recreation |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2017/07/04 09:58:23 |
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Basic information
Public title
Verification of the effect to prevent dementia of dual-task and N-back task by recreation
Acronym
Validation of Dual-task and N-back task
Scientific Title
Verification of the effect to prevent dementia of dual-task and N-back task by recreation
Scientific Title:Acronym
Validation of Dual-task and N-back task
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prophylactic intervention of dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of cognitive function's score/3 months from start of intervention
Key secondary outcomes
Psychological well-being
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Brain training using techniques of dual task and n back task.
Monthly intervention of one year, evaluation every six months.
Interventions/Control_2
Brain training using single task technique
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who can go on their own until the district public hall of the implementation location.
Key exclusion criteria
Those who can not go to the district public hall by themselves.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazue Sawami |
Organization
Nara Medical University
Division name
Faculty of Nursing
Zip code
Address
840 Shijo, Kashihara, Nara JAPAN
TEL
0744-22-3051
sawami@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazue Sawami |
Organization
Nara Medical University
Division name
Faculty of Nursing
Zip code
Address
840 Shijo, Kashihara, Nara JAPAN
TEL
0744-22-3051
Homepage URL
sawami@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Kashihara City Council of Social Welfare of Community Support Service Center
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
奈良県立医科大学（奈良県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1. Correlation between cognitive ability and stress (salivary alpha-amylase), cognitive ability and mental health (GHQ-12) were clarified.:Relationship between Mental Health/Stress Levels and Cognitive Function. Journal of Addiction Research.
2. The cognitive performance and body composition (muscle mass, etc.) are correlated, in particular showed a strong correlation with vascular age.:Relationship between cognitive function, vascular age and stress. International Journal of Case Studies in Clinical Research.
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
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The course of research activities:
http://www.g-nursing.com/katsudou.php
Management information
Registered date
| 2016 | Year | 12 | Month | 31 | Day |
Last modified on
| 2017 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028956
