UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between muscle swelling immediately after resistance training and muscle hypertrophy
Acronym	Relationship between muscle swelling and muscle hypertrophy
Scientific Title	Relationship between muscle swelling immediately after resistance training and muscle hypertrophy
Scientific Title:Acronym	Relationship between muscle swelling and muscle hypertrophy
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to identify the relationship between the degree of muscle swelling immediately after resistance training and muscle hypertrophy caused by intervention of resistance training.
Basic objectives2	Others
Basic objectives -Others	We investigate whether the measure of the degree of muscle swelling immediately after exercise is effective indicator of potential degree of muscle hypertrophy.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Acute change of muscle thickness before and after a trial of resistance training 2) Change of muscle thickness before and after intervention
Key secondary outcomes	1) Maximum voluntary isometric contraction 2) One-repetition maximum 3) Change in muscle strength before and after exercise as an indicator of muscle fatigue

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
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	Resistance training
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	40 years-old >
Gender	Male
Key inclusion criteria	Healthy men who understand the explanation of the study and the instruction of the exercise
Key exclusion criteria	Subjects with a history of orthopedic or neurological disease in their limbs
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Tome Middle name Last name Ikezoe
Organization	Kyoto University
Division name	Human Health Science, Graduate School of Medicine
Zip code	606-8507
Address	53, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3967
Email	ikezoe.tome.4u@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Hirono
Organization	Kyoto University
Division name	Human Health Science, Graduate School of Medicine
Zip code	606-8507
Address	53, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3967
Homepage URL
Email	hirono.tetsuya.56x@st.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University, Human Health Science, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kyoto University, Human Health Science, Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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	京都大学大学院(京都府)

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	26
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	2017 Year 07 Month 31 Day
Date of IRB	2017 Year 07 Month 11 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2020 Year 07 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 28 Day
Last modified on	2020 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032538