UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045313 |
|---|---|
| Receipt number | R000051747 |
| Scientific Title | An Observational Study on Fatigue and Athletic Performance in Athletes |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2022/03/31 11:47:53 |
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Basic information
Public title
An Observational Study on Fatigue and Athletic Performance in Athletes
Acronym
Fatigue and Performance in Athletes
Scientific Title
An Observational Study on Fatigue and Athletic Performance in Athletes
Scientific Title:Acronym
Fatigue and Performance in Athletes
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between blood lactate concentration and fatigue or performance during games in elite volleyball athletes.
Basic objectives2
Others
Basic objectives -Others
A Cross-sectional study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood lactate concentration
Blood glucose level
Subjective questionnaire assessment (VAS, Rate of perceived exertion:RPE)
Exercise performance
Reaction time
Questionnaire
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Female aged 20 years old or more
2) Volleyball player belonging to the execution organization.
Key exclusion criteria
1) Subjects who can not perform training or games.
2) Subjects who are pregnant, breastfeeding, or willing to become pregnant.
3) Subjects who are judged inappropriate for the study by the physician.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Hashimoto |
Organization
Himeji Victorina Co., LTD.
Division name
President
Zip code
670-0902
Address
2F Shirasagi Shiroganemachi Building, 86 Shiroganemachi, Himeji-City, Hyogo-pref.
TEL
079-287-6522
himeji@victorina-vc.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kitamura |
Organization
Morinaga Milk Industry Co., LTD.
Division name
Wellness & Nutrition Science Institute, R&D Division
Zip code
252-8583
Address
1-83,5-Chome, Higashihara, Zama-City, Kanagawa-pref.
TEL
046-252-3046
Homepage URL
yo-kitamura@morinagamilk.co.jp
Sponsor or person
Institute
Himeji Victorina Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro, Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@jccr.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
| 2021 | Year | 08 | Month | 31 | 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
| 2021 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
To clarify the relationship between blood lactate concentration and fatigue or performance during games in elite volleyball athletes.
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051747
