UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between mood changes and brain activity on running.
Title of the study (Brief title)	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	Ryoichi Nagatomi
Organization	Tohoku University
Division name	Graduate school of biomedical engineering
Address	2-1, Seiryo-machi, Aoba-ku, SENDAI 980-8575
TEL	0227178588
Email	nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person	Mihoko Onishi
Organization	Tohoku University
Division name	Graduate school of biomedical engineering
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022530