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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029672
Receipt No. R000033906
Scientific Title The relationship among exercise habit, cognitive functions, and mental health
Date of disclosure of the study information 2017/10/23
Last modified on 2017/10/23

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Basic information
Public title The relationship among exercise habit, cognitive functions, and mental health
Acronym Exercise habits, cognition and mental health
Scientific Title The relationship among exercise habit, cognitive functions, and mental health
Scientific Title:Acronym Exercise habits, cognition and mental health
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to investigate the relationship among exercise habit, cognitive function, and mental health in all generation.
Basic objectives2 Others
Basic objectives -Others In addition, we test exercise habit can predict future cognitive and motor functions and mental health.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function(FAB, stroop, MMSE, Raven, JART, Logical memory, digit span, D-CAT, symbol
search, digit symbol coding)
Key secondary outcomes Motor function(step aerobics, grip, anteflexion, standing on a single leg, Tap and Go)

Mental health(STAI, WHO-5, GHQ12: General Health Questionnaire 12, POMS, CES-D)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 adults from 18 to 24 years old
They receive psychological and motor tests at pre (start), after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months.
Interventions/Control_2 adults from 25 to 44 years old
They receive psychological and motor tests at pre (start), after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months.
Interventions/Control_3 adults from 45 to 65 years old
They receive psychological and motor tests at pre (start), after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months.
Interventions/Control_4 adults from 65 to 80 years old
They receive psychological and motor tests at pre (start), after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Healthy Japanese adults (age from 18 to 80)
Key exclusion criteria We will exclude the subjects with mental disorder, diabetes, cranial nerve disease, cardiac disease, and high blood pressure. The subject have a limitation of exercise.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuta Kwashima
Organization IDAC, Tohoku univeristy
Division name Advanced brain image
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 Univeristy
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 IDAC, Tohoku Univerisity
Institute
Department

Funding Source
Organization Curves Japan
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 10 Month 23 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
2017 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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

Management information
Registered date
2017 Year 10 Month 23 Day
Last modified on
2017 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033906

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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