UMIN-CTR Clinical Trial

Basic information
Public title	Information processing in the non-conscious reaction of soccer players
Acronym	Information processing in the non-conscious reaction of soccer players
Scientific Title	Information processing in the non-conscious reaction of soccer players
Scientific Title:Acronym	Information processing in the non-conscious reaction of soccer players
Region	Japan

Condition
Condition	Healthy adult males
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of intermittent exercise on cognitive function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fluctuations in event-related potentials(P100,N200,P300)due to intermittent exercise
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Rest(Control)
Interventions/Control_2	Moderate Intensity
Interventions/Control_3	High Intensity
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	39 years-old >
Gender	Male
Key inclusion criteria	1. No neurological or psychiatric disorders. 2. Soccer player who normal visual acuity of 0.3 or more in one eye. 3. Soccer player who exercise regularly (>=60 min/day, >=4 times/week) 4. Male 5. Age <= 20 years old to >= 39 years old at the time of informed consent
Key exclusion criteria	None
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Matsutake
Organization	Osaka Metropolitan University Graduate School of Medicine
Division name	Environmental Physiology for Exercise
Zip code	558-8585
Address	3-3-138 Sugimoto, Sumiyoshi, Osaka
TEL	06-6605-2956
Email	matsutake@omu.ac.jp

Public contact
Name of contact person	1st name Takahiro Middle name Last name Matsutake
Organization	Osaka Metropolitan University Graduate School of Medicine
Division name	Environmental Physiology for Exercise
Zip code	558-8585
Address	3-3-138 Sugimoto, Sumiyoshi, Osaka
TEL	06-6605-2956
Homepage URL
Email	matsutake@omu.ac.jp

Sponsor
Institute	Osaka Metropolitan University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Metropolitan University
Address	1-4-3 Asahi-machi, Abeno, Osaka
Tel	06-6645-3457
Email	ethics@med.osaka-cu.ac.jp

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	2022 Year 10 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 10 Month 10 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	2022 Year 07 Month 13 Day
Last modified on	2022 Year 07 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055030