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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033054
Receipt No. R000037687
Scientific Title The acute benefit of combined physical and cognitive training on brain activity
Date of disclosure of the study information 2018/06/19
Last modified on 2019/06/20

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Basic information
Public title The acute benefit of combined physical and cognitive training on brain activity
Acronym The acute benefit of combined physical and cognitive training on brain activity
Scientific Title The acute benefit of combined physical and cognitive training on brain activity
Scientific Title:Acronym The acute benefit of combined physical and cognitive training on brain activity
Region
Japan

Condition
Condition Healthy older adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our purpose is to investigate the benefit of combined cognitive and exercise training on brain activity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes brain activity during stroop task
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Combined brain training and high intensity exercise training
Interventions/Control_2 Combined brain training and low intensity exercise training
Interventions/Control_3 Combined Tetris and high intensity exercise training
Interventions/Control_4 Combined Tetris and low intensity exercise training
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria right handed Japanese older adults (age:60-70)
video game time is less than 1 hour per week last 2 years
Key exclusion criteria We will exclude the subjects with mental disorder, diabetes, cranial nerve disease, cardiac disease, and hyper tension.
In addition, person who is depressive symptom, lower cognitive performance, metal implants, and claustrophobia. Person who can not conduct exercise training is also excluded.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuta Kawashima
Organization IDAC, Tohoku univeristy
Division name Advanced brain science
Zip code
Address Sendai, seiryo-machi 4-1
TEL 022-717-7988
Email fbi@idac.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rui Nouchi
Organization Tohoku University
Division name Smart aging research center
Zip code
Address Sendai, Seiryo-machi4-1
TEL 022-717-7988
Homepage URL
Email rui.nouchi.a4@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 19 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
2018 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 26 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
2018 Year 06 Month 19 Day
Last modified on
2019 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037687

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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