UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062335 |
|---|---|
| Receipt number | R000071042 |
| Scientific Title | Relationship between mental and physical mixed emotions during exercise and individual traits |
| Date of disclosure of the study information | 2026/07/27 |
| Last modified on | 2026/07/24 20:07:46 |
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Basic information
Public title
Relationship between mental and physical mixed emotions during exercise and individual traits
Acronym
Mixed emotions during exercise and psycho-physical traits
Scientific Title
Relationship between mental and physical mixed emotions during exercise and individual traits
Scientific Title:Acronym
Mixed emotions during exercise and psycho-physical traits
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the emotional mechanisms underlying the impact of exercise habits and individual traits on mixed emotions during exercise
Basic objectives2
Others
Basic objectives -Others
Elucidation of the mechanisms underlying mixed emotions during exercise
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Scores and time-course changes of visual analogue scales for mental and physical pleasure/displeasure measured during steady-state exercise
Key secondary outcomes
Subjective data from questionnaires (mood, motivation for exercise, interoceptive awareness, exercise enjoyment, daily exercise habits); Heart rate and Oxygen uptake during exercise; Age; Height; Body weight; Body mass index ; Menstrual cycle; Physical activity data (step count, activity duration, metabolic equivalents)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Low-intensity exercise, Moderate-intensity exercise
Interventions/Control_2
Moderate-intensity exercise, Low-intensity exercise
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy adults with no medical restrictions on exercise and who are not taking any regular medications (including low-dose oral contraceptives).
Key exclusion criteria
Current smokers; women who are pregnant or may be pregnant; individuals with severely irregular menstrual cycles (cycle length of 24 days or less, or 39 days or more over the past 3 months, or cycle-to-cycle variation of 7 days or more); or individuals with amenorrhea
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshikawa |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Sports Medicine
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3790
tkhr6719@omu.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshikawa |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Sports Medicine
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3790
Homepage URL
https://www.omu.ac.jp/med/sportsmed/
tkhr6719@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Takahiro Yoshikawa
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Medical Research, Osaka Metropolitan University
Address
1-2-7, Asahi-machi, Abeno-ku, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.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
大阪公立大学大学院医学研究科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 27 | 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
| 2026 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 07 | Month | 24 | Day |
Last modified on
| 2026 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071042
