UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000048361
Receipt number R000055030
Scientific Title Information processing in the non-conscious reaction of soccer players
Date of disclosure of the study information 2022/10/01
Last modified on 2022/07/13 14:16:20

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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 or person

Institute

Osaka Metropolitan University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name