UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044703
Receipt number R000051042
Scientific Title The effect of daily life exercise on creative thinking
Date of disclosure of the study information 2021/06/29
Last modified on 2023/07/04 09:08:42

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Basic information

Public title

The effect of daily life exercise on creative thinking

Acronym

The effect of daily life exercise on creative thinking

Scientific Title

The effect of daily life exercise on creative thinking

Scientific Title:Acronym

The effect of daily life exercise on creative thinking

Region

Japan


Condition

Condition

na

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether daily life exercise, such as using stairs, affects creative thinking.

Basic objectives2

Others

Basic objectives -Others

To investigate whether the effect of daily life exercise on creative thinking depends on post-exercise mood and other personal characteristics.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation by creative thinking tests. Specifically, for the evaluation of divergent thinking, we will employ the Alternative Uses Test; for the evaluation of convergent thinking, we will employ matchstick-based problem-solving tests.

Key secondary outcomes

1) Whether the effect of exercise is affected by heart rates during exercise and mood after exercise, etc.
2) Whether the effect of exercise is affected by physical activity levels, grip strength, and other personal characteristics
3) Relationships among other personal characteristics


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and 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: starting from the laboratory room on the 4th floor, walking downstairs to the entrance of the building and then walking upstairs back to the laboratory room.

Interventions/Control_2

Controlled intervention: using the elevator, starting from the laboratory room on the 4th floor, going to the entrance of the building and then coming back to the laboratory room.

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 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.
2) Those who are judged to be unsuitable as research subjects by the researcher in charge of the experimental sessions (for example, a person who has attended our previous study "The effects of physical exercise on creative thinking" or who cannot conduct the exercise intervention smoothly).

Target sample size

22


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 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

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



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 29 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

2021 Year 06 Month 28 Day

Date of IRB

2021 Year 06 Month 29 Day

Anticipated trial start date

2021 Year 07 Month 05 Day

Last follow-up date

2023 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

2021 Year 06 Month 29 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=R000051042


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name