UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048494 |
|---|---|
| Receipt number | R000054959 |
| Scientific Title | Conditioning evaluation and practice on University road relay athletes using oxidative stress |
| Date of disclosure of the study information | 2022/08/03 |
| Last modified on | 2022/07/28 09:24:52 |
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Basic information
Public title
Conditioning evaluation and practice on University road relay athletes using oxidative stress
Acronym
Conditioning evaluation and practice on University road relay athletes using oxidative stress
Scientific Title
Conditioning evaluation and practice on University road relay athletes using oxidative stress
Scientific Title:Acronym
Conditioning evaluation and practice on University road relay athletes using oxidative stress
Region
| Japan |
Condition
Condition
Healthy male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the relation of performance, training, diet, sleep, etc. and oxidative stress conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxidative stress (Reactive Oxygen Metabolites), Antioxidant ability (BAP)
Key secondary outcomes
urine specific gravity, resting heart rate, body weight, body temperature, sleep time, sleep quality, presence or absence of injury, fatigue, willingness to practice, physical condition, appetite, training distance, training intensity, training achievement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
Pointing out the condition index that had a problem
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male university students who belong to the relay road race team.
Subjects who understand the design of this study and provide informed consent with it.
Subjects who are over 18 years old.
Key exclusion criteria
Those who do not have sports injuries at the start of the study
Target sample size
15
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-shi, 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-shi, Saitama
TEL
049-271-8042
Homepage URL
ishikura@josai.ac.jp
Sponsor or person
Institute
Josai University
Institute
Department
Personal name
Funding Source
Organization
Josai University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Science / Medical Research Ethics Review Board for Humans
Address
1-1, Keyakidai, Sakado-shi, Saitama
Tel
049-271-7735
jikken@stf.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
| 2022 | Year | 08 | Month | 03 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 07 | Month | 28 | Day |
Last modified on
| 2022 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054959
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
