UMIN-CTR Clinical Trial

Basic information
Public title	Effect of repetitions of strength training on muscle hypertrophy in untrained healthy young adults
Acronym	Effect of repetitions of strength training on muscle hypertrophy in untrained healthy young adults
Scientific Title	Dose-response of repetitions of resistance training on muscle hypertrophy in untrained healthy young adults
Scientific Title:Acronym	Dose-response of repetitions of resistance training on muscle hypertrophy in untrained healthy young adults
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	he aim of this study is to compare the effect of 3, 5, 7, and 10 repetitions per 1 set on the change of muscle hypertrophy due to 12 weeks resistance training in untrained healthy young adults, and to clarify that there is a dose-response relationship between repetitions and the changes in muscle hypertrophy .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle mass 12 weeks after the start of the intervention
Key secondary outcomes	Muscle strength 12 weeks after the start of the intervention Muscle thickness 12 weeks after the start of the intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Subjects perform leg press and chest press, with training performed twice a week for 12 weeks. This group is performed 3 set x 10 repetitions at training load of 10 repetition maximum(RM).
Interventions/Control_2	Subjects perform leg press and chest press, with training performed twice a week for 12 weeks. This group is performed 3 set x 7 repetitions at training load of 10 RM.
Interventions/Control_3	Subjects perform leg press and chest press, with training performed twice a week for 12 weeks. This group is performed 3 set x 5 repetitions at training load of 10 RM.
Interventions/Control_4	Subjects perform leg press and chest press, with training performed twice a week for 12 weeks. This group is performed 3 set x 3 repetitions at training load of 10 RM.
Interventions/Control_5	Control
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	35 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who have not been regularly resistance training for the past year
Key exclusion criteria	Subjects with orthopedic diseases or their history that may interfere with resistance training Subjects with nervous system diseases or their history that may interfere with resistance training Subjects with internal medical diseases or their history that may interfere with resistance training Subjects with other subjective symptoms that may interfere with resistance training Subjects using a pacemaker Subjects judged by the principal investigator to be inappropriate as subjects
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Hotaka Middle name Last name Sugimoto
Organization	Shinshu university
Division name	Department of Physical Therapy
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	+81-263-37-2413
Email	hsugimoto@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Hotaka Middle name Last name Sugimoto
Organization	Shinshu university
Division name	Department of Physical Therapy
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	+81-263-37-2413
Homepage URL
Email	hsugimoto@shinshu-u.ac.jp

Sponsor
Institute	Shinshu university
Institute
Department

Funding Source
Organization	None
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	Shinshu University School of Medicine Ethics Committee Secretariat
Address	3-1-1 Asahi, Matsumoto, Nagano
Tel	+81-263-37-2572
Email	mdrinri@shinshu-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	2020 Year 10 Month 15 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	Open public recruiting
Date of protocol fixation	2020 Year 08 Month 27 Day
Date of IRB	2020 Year 10 Month 12 Day
Anticipated trial start date	2020 Year 10 Month 15 Day
Last follow-up date	2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 14 Day
Last modified on	2022 Year 04 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048056