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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041122
Receipt No. R000046829
Scientific Title The effects of physical exercise on creative thinking
Date of disclosure of the study information 2020/07/16
Last modified on 2020/07/15

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Basic information
Public title The effects of physical exercise on creative thinking
Acronym The effects of physical exercise on creative thinking
Scientific Title The effects of physical exercise on creative thinking
Scientific Title:Acronym The effects of physical exercise on creative thinking
Region
Japan

Condition
Condition na
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether acute, transient exercises with intensities greater than walking can affect divergent and convergent creative thinking. To investigate what characteristics of the study subjects regulate this effect.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation by creative thinking test. Specifically, in the analysis of the main evaluation, the change in creative thinking before and after the intervention is compared between the exercise intervention group and the control intervention group.
For the evaluation of divergent thinking, we will employ the Alternative Uses Test; for the evaluation of convergent thinking, we will employ insight problem-solving tests.
Key secondary outcomes 1) Comparison of mood evaluation by visual analog scale immediately after each intervention in the exercise intervention group and the control intervention group
2) Whether the effects of exercise intervention are affected by personal characteristics such as mental status and cognitive functions
3) The relationship between creative thinking evaluated before exercise intervention and other personal characteristics
4) Relationships among other personal characteristics

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise intervention: Using the exercise program based on the "physical fitness test program" of an exercise bike (Fukuda Denshi Wellbike BE-260). The program includes 10 minutes of exercise and 5 minutes of cooldown. Under this program, the pedal load increases 4 and 7 minutes after the start of the program, and the maximum oxygen intake, which is an index of aerobic ability, is estimated from the change in the pulse rate with respect to the pedal load.
Interventions/Control_2 Controlled intervention: A reading session lasts about 15 minutes, in which subjects are asked to read a set of material on "the effect of exercise on the brain" while quietly seated.
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
20 years-old <=
Age-upper limit
29 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age is 20 to 29 at the time of obtaining consent.
2) Regardless of gender.
3) A person who, after receiving a sufficient explanation before participating in this research, has a sufficient understanding and provided informed consent.
Key exclusion criteria 1) Those who have a history of diseases that greatly affect cardiopulmonary function such as chronic heart failure.
2) Those who are currently suffering from a mental illness or are currently undergoing medical examination (including those who are scheduled to undergo medical examination) by self-declaration.
3) Staff of our department who receive the personnel evaluation directly by the principal investigator of this study.
4) Those who are judged to be unsuitable as research subjects by the researcher in charge of the experimental sessions (for example, a person who exceeds the applicable weight of the exercise bike used for exercise).
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shin
Middle name
Last name Nakagawa
Organization Yamaguchi University Graduate School of Medicine
Division name Division of Neuropsychiatry, Department of Neuroscience
Zip code 7558505
Address Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL 0836222255
Email brain@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Chong
Middle name
Last name Chen
Organization Yamaguchi University Graduate School of Medicine
Division name Division of Neuropsychiatry, Department of Neuroscience
Zip code 7558505
Address Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL 0836222255
Homepage URL
Email brain@yamaguchi-u.ac.jp

Sponsor
Institute Division of Neuropsychiatry, Department of Neuroscience, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional Review Board Committee in Yamaguchi University Hospital
Address Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
Tel 0836222428
Email clin_res@yamaguchi-u.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 山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 16 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
2020 Year 07 Month 06 Day
Date of IRB
2020 Year 07 Month 07 Day
Anticipated trial start date
2020 Year 07 Month 20 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 16 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046829

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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