UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029672 |
|---|---|
| Receipt number | 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 16:26:49 |
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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
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
rui.nouchi.a4@tohoku.ac.jp
Sponsor or person
Institute
IDAC, Tohoku Univerisity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033906
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
