UMIN-CTR Clinical Trial

Basic information
Public title	Changing muscle temperature by warming up and using protections against cold
Acronym	Changing Muscle temperature
Scientific Title	Changing muscle temperature by warming up and using protections against cold
Scientific Title:Acronym	Changing Muscle temperature
Region	Japan

Condition
Condition	Normal
Classification by specialty	Medicine in general Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove whether muscle temperature is change or not by the kind of warming up that is said it is important to privent from injuries in sports. To prove whether muscle temperature is change or not and to help priventing from injuries in sports by using protection against cold.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	muscle temperature(before intervention, 30 minutes after intervention)
Key secondary outcomes	height, weight, distance about running, time about running, blood pressure, pulse

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Instructing exercise to warm-up
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	Male and Female
Key inclusion criteria	Normal people
Key exclusion criteria	People who has ever had disease that prevents from exercise
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoshi Hakukawa
Organization	School of medicine, Keio University
Division name	Institute for integrated Sports Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	81710060@keio.jp

Public contact
Name of contact person	1st name Middle name Last name Satoshi Hakukawa
Organization	School of medicine, Keio University
Division name	Institute for integrated Sports Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	81710060@keio.jp

Sponsor
Institute	School of medicine, Keio University
Institute
Department

Funding Source
Organization	Inc. J S
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
Address
Tel
Email

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	2018 Year 03 Month 12 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	2018 Year 03 Month 12 Day
Date of IRB	2018 Year 03 Month 23 Day
Anticipated trial start date	2018 Year 05 Month 02 Day
Last follow-up date	2019 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	2018 Year 03 Month 07 Day
Last modified on	2019 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035306