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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036313
Receipt No. R000041355
Scientific Title Elucidating the impact of daily activities on cognition and mental function
Date of disclosure of the study information 2019/03/27
Last modified on 2019/03/27

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Basic information
Public title Elucidating the impact of daily activities on cognition and mental function
Acronym Elucidating the impact of daily activities on cognition and mental function
Scientific Title Elucidating the impact of daily activities on cognition and mental function
Scientific Title:Acronym Elucidating the impact of daily activities on cognition and mental function
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship between daily activities and cognitive and mental functions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stroop task
Profile of Mood States 2nd Edition
The Two-Dimensional Mood Scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Daily activity task
Interventions/Control_2 Exercise task
Interventions/Control_3 Control task
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria right-handed elderly people
Key exclusion criteria Physically and mentally handicapped person who can not perform tasks.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Tsuchiya
Organization Gunma University Graduate School of Health Sciences
Division name Department of Rehabilitation Sciences
Zip code 3718514
Address 3-39-22 Showa, Maebashi, Gunma, Japan
TEL 027-220-8993
Email tkenji@gunma-u.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Tsuchiya
Organization Gunma University Graduate School of Health Sciences
Division name Department of Rehabilitation Sciences
Zip code 3718514
Address 3-39-22 Showa, Maebashi, Gunma, Japan
TEL 0272208993
Homepage URL
Email tkenji@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Japan Society for the promotion of science and Gunma University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Gunma University
Address 3-39-15 Showa, Maebashi, Gunma, Japan
Tel 0275528740
Email hitotaisho-ciru@ml.gunma-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
2019 Year 03 Month 27 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
2019 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 09 Day
Last follow-up date
2024 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041355

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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