UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061132 |
|---|---|
| Receipt number | R000069611 |
| Scientific Title | Investigation of associations between changes in cerebral blood flow and oxygen metabolism and exerkines evoked by high-intensity exercise; a study using positron emission tomography (PET) |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/04/04 12:04:16 |
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Basic information
Public title
Investigation of associations between changes in cerebral blood flow and oxygen metabolism and exerkines (particles derived from contracting muscles) evoked by high-intensity exercise; a study using positron emission tomography (PET)
Acronym
Associations between cerebral blood flow, oxygen metabolism and exerkines evoked by high-intensity exercise
Scientific Title
Investigation of associations between changes in cerebral blood flow and oxygen metabolism and exerkines evoked by high-intensity exercise; a study using positron emission tomography (PET)
Scientific Title:Acronym
Associations between cerebral blood flow, oxygen metabolism and exerkines evoked by high-intensity exercise
Region
| Japan |
Condition
Condition
Healthy young men
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Regional cerebral blood flow (CBF) is investigated after the session of high-intensity aerobic exercise so that the relationships between regional CBF and blood exerkines levels, such as irisin, BDNF and cathepsin B, which have roles for neural plasticity and neuroprotective effect, are explored.
To identify the coupling of CBF and oxygen metabolism in the prefrontal cortex (PFC), that regulates will to perform exercise and involves the underlying mechanism for mood change, the ratio of CBF to metabolic rate for oxygen (CMRO2) is analyzed by simultaneous measurements using PET and near infrared spectroscopy, which enables to calculate CMRO2 applying cerebral hemoglobin oxygen saturation. We also clarify exercise-related self-efficacy, state of stress and fatigue and personal characteristics in traits that are related with mood change induced by exercise.
Basic objectives2
Others
Basic objectives -Others
Research for physiology which focuses on cerebral hemodynamics and oxygen metabolism and blood exerkines level evoked by exercise
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Regional CBF, CMRO2 in the prefrontal cortex, blood exerkines levels (BDNF, irisin and cathepsin B etc.), mood change (measured by scaling scores)
Key secondary outcomes
Respiratory variables (minute ventilation, partial pressure of arterial carbon dioxide), circulatory dynamics (heart rate, blood pressure), participants' exercise self-efficacy, personality traits, and perceived exertion during exercise
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
At rest and exercise intervention of 28 min (vigorous-intensity cycling exercise followed by a moderate-intensity bout)
Interventions/Control_2
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
Male
Key inclusion criteria
Healthy young men who have been engaged in high-intensity aerobic exercise and can tolerate 28 minutes of moderate to vigorous aerobic exercise.
Key exclusion criteria
1. A history of neuropsychiatric disorders such as epilepsy, major depression, or schizophrenia.
2. Habit of smoke.
3. Contraindication for head MRI examination.
4. A history of severe drug hypersensitivity.
5. A history of cardiovascular disease.
6. Current diagnosis of internal diseases such as chronic anemia or chronic renal failure.
7. Any other reason by which the principal investigator determines to exclude from the participation for this study
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Toyohara |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
toyohara@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | Mikio |
| Middle name | |
| Last name | Hiura |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
hiura@pet.tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department
Personal name
Mikio Hiura
Funding Source
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, Tokyo Metropolitan Geriatric Center
Address
Sakaecho 35-2, Itabashi-ku, Tokyo
Tel
03-3964-3241
naomi_hasegawa@tmghig.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
| 2026 | Year | 04 | Month | 06 | 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
| 2025 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069611
