UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033054 |
|---|---|
| Receipt number | 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 09:06:33 |
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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
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
rui.nouchi.a4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037687
