UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019485 |
|---|---|
| Receipt number | R000022530 |
| Scientific Title | The relationship between mood changes and brain activity on running. |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2017/04/25 09:51:09 |
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Basic information
Public title
The relationship between mood changes and brain activity on running.
Acronym
The relationship between mood changes and brain activity on running.
Scientific Title
The relationship between mood changes and brain activity on running.
Scientific Title:Acronym
The relationship between mood changes and brain activity on running.
Region
| Japan |
Condition
Condition
healthy amateur runner
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The runner's high phenomenon describes a euphoric state resulting from long distance running. The runner's high phenomenon often compared to happiness, euphoria, anxiolysis and reduced pain perception. So far this mechanism isn't clarified, because the endorphin hypothesis was indirectly measured raised endorphin levels in peripheral blood. The aim of this study is to clarify between mood changes to perceived euphoria and brain activity on running.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between mood changes and brain activity on running.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electroencephalography, mood changes, peripheral lactic acid, heart rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
running30minutes
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants are regular runners or endurance athletes. For inclusion in this study, they are required a minimum of 3 times weekly training and more than 30 minutes once a training. They include 5 females and 5 males.
Key exclusion criteria
For exclusion in this study, who have a musculoskeletal disease, circulatory disease and chronic disease (diabetes mellitus, hyper tension, etc.).
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Nagatomi |
Organization
Tohoku University
Division name
Graduate school of biomedical engineering
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, SENDAI 980-8575
TEL
0227178588
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mihoko Onishi |
Organization
Tohoku University
Division name
Graduate school of biomedical engineering
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, SENDAI 980-8575
TEL
0227178588
Homepage URL
m-onishi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding 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
| 2015 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | 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
| 2015 | Year | 10 | Month | 24 | Day |
Last modified on
| 2017 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022530
| 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 |
