UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055905 |
|---|---|
| Receipt number | R000063880 |
| Scientific Title | The exercise method as mental health care on sex-specific circulating endocannabinoids levels |
| Date of disclosure of the study information | 2024/10/23 |
| Last modified on | 2025/04/22 09:26:01 |
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Basic information
Public title
The exercise method as mental health care on sex-specific circulating endocannabinoids levels
Acronym
The exercise method as mental health care on sex-specific circulating endocannabinoids levels
Scientific Title
The exercise method as mental health care on sex-specific circulating endocannabinoids levels
Scientific Title:Acronym
The exercise method as mental health care on sex-specific circulating endocannabinoids levels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the changes in blood endocannabinoid concentrations and mood indices induced by moderate-intensity exercise. To achieve this, the biological responses will be observed during long-term exercise.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood endogenous cannabinoid concentration (before and after the intervention, and before and after rest or exercise at sessions 1, 9, and 18)
Key secondary outcomes
Heart rate
Rating of perceived exertion
Mood index (Physical activity affect scale, Depression anxiety stress scales, Patient health questionnaire)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The resting group will maintain a resting state for 10 minutes. The frequency and duration of exercise will be 3 sessions per week for 6 weeks.
Interventions/Control_2
The exercise group will perform cycle exercise equivalent to 50% HRreserve on a watt bike for 10 minutes. The frequency and duration of exercise will be 3 sessions per week for 6 weeks.
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
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People without exercise habits
Key exclusion criteria
People with abnormal items in health checks.
People who take any kind of medication
Smokers
People who cannot conduct exercise at the intensity set in this study.
People who have ever lost consciousness during blood sampling.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yabe |
Organization
Yamanashi Gakuin University
Division name
Faculty of Sport Science
Zip code
400-8575
Address
Sakaori2-4-5, Kofu-shi, Yamanashi, Japan
TEL
055-224-1377
yabe.tetsuya@c2c.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yabe |
Organization
Yamanashi Gakuin University
Division name
Faculty of Sport Science
Zip code
400-8575
Address
Sakaori2-4-5, Kofu-shi, Yamanashi, Japan
TEL
055-224-1377
Homepage URL
yabe.tetsuya@c2c.ac.jp
Sponsor or person
Institute
Yamanashi Gakuin University
Institute
Department
Personal name
Tetsuya Yabe
Funding Source
Organization
other
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
The Ethics Committee of Yamanashi Gakuin University
Address
Sakaori2-4-5, Kofu-shi, Yamanashi, Japan
Tel
055-224-1234
academicaffairs@c2c.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 | 10 | Month | 23 | 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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063880
