UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048280 |
|---|---|
| Receipt number | R000055017 |
| Scientific Title | The effect of everyday life physical activity on creative thinking |
| Date of disclosure of the study information | 2022/07/05 |
| Last modified on | 2024/07/08 14:01:17 |
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Basic information
Public title
The effect of everyday life physical activity on creative thinking
Acronym
The effect of everyday life physical activity on creative thinking
Scientific Title
The effect of everyday life physical activity on creative thinking
Scientific Title:Acronym
The effect of everyday life physical activity on creative thinking
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether everyday life physical activity, such as stair-climbing, affects creative thinking. In addition, to investigate whether the effect of everyday life physical activity on creative thinking depends on post-physical activity mood and subjects' personal characteristics
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Divergent thinking, as evaluated by the alternate uses test.
Convergent thinking, as evaluated by the matchstick puzzle.
Key secondary outcomes
1), whether the effect of physical activity depends on heart rate during and mood after the intervention
2), whether the effect of physical activity depends on regular physical activity, handgrip strength, mental health, and other personal characteristics
3), as additional data analysis, we will investigate the association between 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
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise (Stair-climbing 2 floors up): starting from the 7th floor of our research building move to the 9th floor where our laboratory is located, at one's usual paces using stairs
Interventions/Control_2
Exercise (Stair-climbing 5 floors up): starting from the 4th floor of our research building move to the 9th floor where our laboratory is located, at one's usual paces using stairs
Interventions/Control_3
Exercise (Stair-climbing 8 floors up): starting from the 1th floor of our research building move to the 9th floor where our laboratory is located, at one's usual paces using stairs
Interventions/Control_4
Control (Elevator 8 floors up): starting from the 1th floor of our research building move to the 9th floor where our laboratory is located, at one's usual paces using the elevator
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
Those who can provide written informed consent after receiving a detailed explanation of the study
Key exclusion criteria
1), being diagnosed with any mental disorders, receiving or being scheduled to receive medical examinations due to suspicion of mental disorders.
2), having attended our previous studies on exercise/physical activity and creative thinking.
3), staff of our department who receive personnel assessment from the principle investigator of the study.
4), people judged inappropriate to be subjects of the study
Target sample size
52
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
755-8505
Address
Minami-kogushi 1-1-1, Ube, Japan
TEL
0836-22-2254
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
755-8505
Address
Minami-kogushi 1-1-1, Ube, Japan
TEL
0836-22-2254
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
Division of Neuropsychiatry, Department of Neuroscience, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
Minami-kogushi 1-1-1, Ube, Japan
Tel
0836-22-2428
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
Yamaguchi University Hospital
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055017
