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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025484
Receipt No. 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

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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
Email 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
Email sawami@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028956

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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