UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053031 |
|---|---|
| Receipt number | R000060384 |
| Scientific Title | Investigation of marathon-induced muscle damage |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2025/06/08 11:38:21 |
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Basic information
Public title
Investigation of marathon-induced muscle damage
Acronym
Investigation of marathon-induced muscle damage
Scientific Title
Investigation of marathon-induced muscle damage
Scientific Title:Acronym
Investigation of marathon-induced muscle damage
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between the total impact force during marathon running and marathon-induced muscle damage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total impact force during marathon, serum creatine kinase activity
Key secondary outcomes
serum myoglobin, serum AST, serum ALT, serum LDH, serum CRP, white blood cell component
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who will participate in either the 2023 or 2024 Tsukuba Marathon.
Key exclusion criteria
No particular settings.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Ishikura |
Organization
Josai University
Division name
Department of Management, Faculty of Management
Zip code
350-0295
Address
1-1, Keyakidai, Sakado, Saitama
TEL
049-271-8042
ishikura@josai.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Ishikura |
Organization
Josai University
Division name
Department of Management, Faculty of Management
Zip code
350-0295
Address
1-1, Keyakidai, Sakado, Saitama
TEL
049-271-8042
Homepage URL
ishikura@josai.ac.jp
Sponsor or person
Institute
Josai University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Josai University
Address
1-1, Keyakidai, Sakado, Saitama
Tel
049-271-8042
ishikura@josai.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
| 2023 | Year | 12 | Month | 07 | 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
23
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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the total impact force at landing and muscle damage paramaters obtained from blood samples during marathon.
Management information
Registered date
| 2023 | Year | 12 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060384
