UMIN-CTR Clinical Trial

Basic information
Public title	The influence of fluid intake interval on performance after high intensity interval exercise in heat environment
Acronym	The study of fluid intake and performance
Scientific Title	The influence of fluid intake interval on anaerobic performance after high intensity interval exercise in heat environment
Scientific Title:Acronym	The study of fluid intake interval and anaerobic performance
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is clarify the influence of fluid intake interval on performance after high intensity interval exercise in heat environment.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	standing long jump, vertical jump
Key secondary outcomes	body weight, tympanic temperature, skin temperature

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	sitting rest > measurement of body weight > warm-up > standing long jump and vertical jump > high intensity interval exercise (two times fluid intake) > standing long jump and vertical jump > cool-down > measurement of body weight
Interventions/Control_2	sitting rest > measurement of body weight > warm-up > standing long jump and vertical jump > high intensity interval exercise (five times fluid intake) > standing long jump and vertical jump > cool-down > measurement of body weight
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	30 years-old >=
Gender	Male
Key inclusion criteria	Healthy male university students who have given written informed consent
Key exclusion criteria	Female, those with motor disorder, those with a history of cardiovascular disease, smokers, those under medication, and those with metal allergy
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Kumiko Middle name Last name ONO
Organization	Kobe University
Division name	Graduate School of Health Sciences
Zip code	654-0142
Address	7-10-2 Tomogaoka, Suma, Hyogo, JAPAN
TEL	078-796-4582
Email	onoku@tiger.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kumiko Middle name Last name ONO
Organization	Kobe University
Division name	Graduate School of Health Sciences
Zip code	654-0142
Address	7-10-2 Tomogaoka, Suma, Hyogo, JAPAN
TEL	078-796-4582
Homepage URL
Email	onoku@tiger.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Kobe 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	Kobe University Graduate School of Health Sciences, Health Sciences Ethical Committee
Address	7-10-2 Tomogaoka, Suma, Kobe-shi, Hyogo
Tel	078-792-2555
Email	syomu2@ams.kobe-u.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	2019 Year 12 Month 26 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	9
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	2019 Year 10 Month 21 Day
Date of IRB	2019 Year 12 Month 02 Day
Anticipated trial start date	2019 Year 12 Month 02 Day
Last follow-up date	2020 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	2019 Year 12 Month 25 Day
Last modified on	2021 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044463