UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041122 |
|---|---|
| Receipt number | R000046829 |
| Scientific Title | The effects of physical exercise on creative thinking |
| Date of disclosure of the study information | 2020/07/16 |
| Last modified on | 2023/07/04 09:10:49 |
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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
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
brain@yamaguchi-u.ac.jp
Sponsor or person
Institute
Division of Neuropsychiatry, Department of Neuroscience, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-3425/11/5/546/htm
Number of participants that the trial has enrolled
40
Results
Exercise enhanced divergent thinking, more specifically, flexibility and fluency but not novelty. These effects were not mediated by the post-exercise mood. In contrast, the effect on convergent thinking depended on subjects' mood after exercise, subjects reporting high vigor tended to solve more insight problems that were unsolved previously, while those reporting low vigor became less capable of solving previously unsolved problems.
Results date posted
| 2022 | Year | 07 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046829
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