UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029681 |
|---|---|
| Receipt number | R000033922 |
| Scientific Title | Acute effects of exercise on cognitive functions and mental health |
| Date of disclosure of the study information | 2017/10/24 |
| Last modified on | 2019/03/20 16:25:55 |
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Basic information
Public title
Acute effects of exercise on cognitive functions and mental health
Acronym
Acute effects of exercise
Scientific Title
Acute effects of exercise on cognitive functions and mental health
Scientific Title:Acronym
Acute effects of exercise
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 acute effects of exercise on cognitive functions and mental health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function(stroop, JART, D-CAT,memory updating, digit symbol coding)
Mental health(STAI, WHO-5, GHQ12: General Health Questionnaire 12, POMS, CES-D)
Key secondary outcomes
grip, 30-second stand and sit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
combination training (single shot 30 minutes excise)
Interventions/Control_2
waiting (30 minutes waiting with reading book)
Interventions/Control_3
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
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
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
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.j
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
Tohoku University
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 | 24 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 01 | Day |
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 | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033922
