UMIN-CTR Clinical Trial

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
Email	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
Email	yo-kitamura@morinagamilk.co.jp

Sponsor
Institute	Himeji Victorina Co., LTD.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051747