UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054839 |
|---|---|
| Receipt number | R000062664 |
| Scientific Title | The effect of a 7-day increase in step count on cognitive function in young adults: an exploratory randomized controlled trial |
| Date of disclosure of the study information | 2024/07/02 |
| Last modified on | 2024/07/01 18:19:13 |
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Basic information
Public title
The effect of a 7-day increase in step count on cognitive function in young adults: an exploratory randomized controlled trial
Acronym
Step count increase and cognitive function test
Scientific Title
The effect of a 7-day increase in step count on cognitive function in young adults: an exploratory randomized controlled trial
Scientific Title:Acronym
Step count increase and cognitive function test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of short-term increases in step count on cognitive function
Basic objectives2
Others
Basic objectives -Others
A study examining the effects of short-term increases in step count (physical activity) on cognitive function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Executive function after a 7-day increase in step count
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Double the usual step count during the 7-day intervention period
Interventions/Control_2
Maintain the usual step count during the 7-day intervention period
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
| 17 | years-old | < |
Age-upper limit
| 31 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Young adults aged 18 to 30 years
Leading an independent lifestyle and free from severe conditions such as heart disease, diabetes, hypertension, etc
Willing to participate in the study
Not experiencing severe premenstrual syndrome
Not engaging in regular exercise training
Key exclusion criteria
Smokers
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Morishima |
Organization
Chukyo university
Division name
Faculty of Liberal Arts and Sciences
Zip code
466-8666
Address
101-2, Yagoto-honmachi, Showa, Nagoya, Aichi
TEL
0565-46-6629
t-morishima@lets.chukyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Morishima |
Organization
Chukyo university
Division name
Faculty of Liberal Arts and Sciences
Zip code
466-8666
Address
101-2, Yagoto-honmachi, Showa, Nagoya, Aichi
TEL
0565-46-6629
Homepage URL
t-morishima@lets.chukyo-u.ac.jp
Sponsor or person
Institute
Chukyo university
Institute
Department
Personal name
Takuma Morishima
Funding Source
Organization
Chukyo university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chukyo university
Address
101-2, Yagoto-honmachi, Showa, Nagoya, Aichi
Tel
052-835-7111
t-morishima@lets.chukyo-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
| 2024 | Year | 07 | Month | 02 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062664
