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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019485
Receipt No. 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

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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
Email 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
Email m-onishi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022530

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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