UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062956 |
|---|---|
| Receipt number | R000072073 |
| Scientific Title | Effects of Acute Aerobic Exercise on Cognitive Performance: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/09/17 |
| Last modified on | 2026/09/17 10:03:52 |
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Basic information
Public title
Effects of Acute Aerobic Exercise on Cognitive Performance
Acronym
Acute Exercise and Cognition
Scientific Title
Effects of Acute Aerobic Exercise on Cognitive Performance: A Randomized Crossover Trial
Scientific Title:Acronym
Acute Exercise and Cognition
Region
| Japan |
Condition
Condition
Maintenance and improvement of cognitive function
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether the effects of acute aerobic exercise on cognitive performance vary depending on cognitive task difficulty. By systematically manipulating task difficulty, we aim to identify the level of task difficulty at which the effects of acute aerobic exercise on cognitive performance are maximized.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
D-prime (sensitivity index) during the n-back task. D-prime will be assessed before and 10 minutes after the intervention. We will examine whether the difference in pre-to-post changes in d-prime between the exercise and seated rest conditions varies with task difficulty.
Key secondary outcomes
1. Reaction time for correct target responses (Hit RT) during the n-back task. Hit RT will be assessed before and 10 minutes after the intervention. We will examine whether the difference in pre-to-post changes in Hit RT between the exercise and seated rest conditions varies with task difficulty.
2. Pupil diameter during the n-back task will be assessed before and 10 minutes after the intervention as an index of cognitive effort. We will examine changes in pupil diameter as a function of task difficulty and investigate the relationship between pupil diameter and the magnitude of the effect of acute aerobic exercise on cognitive performance.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will complete the exercise condition first, followed by the seated rest condition after an interval. The interval between conditions will generally be 3-14 days, although the second session may be postponed due to unavoidable circumstances such as illness. In the exercise condition, participants will perform 20 minutes of cycling exercise on a cycle ergometer at an intensity corresponding to 60-70% of maximal heart rate while watching a neutral video. Cognitive performance will be assessed using the n-back task before and after exercise. In the seated rest condition, participants will remain seated at rest for 20 minutes while watching a neutral video. Cognitive performance will be assessed using the n-back task before and after the rest period.
Interventions/Control_2
Participants will complete the seated rest condition first, followed by the exercise condition after an interval. The interval between conditions will generally be 3-14 days, although the second session may be postponed due to unavoidable circumstances such as illness.
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male and female university students.
Key exclusion criteria
Individuals who are unable to exercise because of illness or injury, current smokers, and individuals with a history of neurological or psychiatric disorders will be excluded. Female participants with irregular menstrual cycles or severe symptoms of premenstrual syndrome will also be excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Kamijo |
Organization
Chukyo University
Division name
Faculty of Liberal Arts and Sciences
Zip code
466-8666
Address
101-2 Yagoto Honmachi, Showa-ku, Nagoya, Aichi
TEL
052-835-7794
k-kamijo@lets.chukyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Kamijo |
Organization
Chukyo University
Division name
Faculty of Liberal Arts and Sciences
Zip code
466-8666
Address
101-2 Yagoto Honmachi, Showa-ku, Nagoya, Aichi
TEL
052-835-7794
Homepage URL
k-kamijo@lets.chukyo-u.ac.jp
Sponsor or person
Institute
Chukyo University
Institute
Department
Personal name
Keita Kamijo
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)
Daiko Foundation
IRB Contact (For public release)
Organization
The Human Research Ethics Committee of Chukyo University
Address
101-2 Yagoto Honmachi, Showa-ku, Nagoya, Aichi
Tel
052-835-8068
kenkyurinri@ml.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
中京大学名古屋キャンパス（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 17 | 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
After publication, de-identified individual participant data underlying the primary and secondary outcome analyses will be shared with researchers who have an appropriate research purpose and receive approval from the principal investigator.
IPD sharing Plan description
Data will be available following publication of the study results, with no predetermined end date. Data sharing requests will be reviewed on a case-by-case basis by the principal investigator based on the proposed research purpose, analysis plan, and any necessary ethical procedures. De-identified individual participant data necessary to achieve the aims of the approved proposal will be provided. The study protocol and analytic code will also be made available upon reasonable request. Requests should be sent to the principal investigator at the email address listed in this registration. Descriptions of variable definitions, units, and coding will accompany the shared data.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The title used for ethical review was "Effects of Acute Exercise on Cognitive Function." A different scientific title is used in this registration to describe the study more specifically.
This study initially received approval from the ethics committee and subsequently underwent several protocol modifications based on a series of pilot experiments and refinements of the study procedures. The present registration is based on the latest version of the study protocol approved by the ethics committee in October 2025.
Management information
Registered date
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072073
