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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026026
Receipt No. R000029914
Scientific Title Changes in skeletal muscle size induced by electrical stimulation training
Date of disclosure of the study information 2017/03/01
Last modified on 2019/11/18

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Basic information
Public title Changes in skeletal muscle size induced by electrical stimulation training
Acronym Changes in muscle size by electrical stimulation training
Scientific Title Changes in skeletal muscle size induced by electrical stimulation training
Scientific Title:Acronym Changes in muscle size by electrical stimulation training
Region
Japan

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

Objectives
Narrative objectives1 Clarify the effects of electrical stimulation training on muscle size
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cross-sectional area of the abdominal muscles before and after 12 weeks of training
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Training of abdominal muscles with an electrical stimulation device
12 weeks
5 days per week
1 session per day (23 minutes)
Interventions/Control_2 Keep their normal life
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
18 years-old <=
Age-upper limit
24 years-old >=
Gender Male
Key inclusion criteria Healthy men
Key exclusion criteria Person with contraindication to MRI, such as having MRI-unsafe device within the body, having tattoo and claustrophobia.
Person with contraindication to electrical stimulation device, such as cardiac disorder and having implant device within the body.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Taku
Middle name
Last name Wakahara
Organization Doshisha University
Division name Faculty of Health and Sports Science
Zip code 610-0394
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-7531
Email twakahar@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name Taku
Middle name
Last name Wakahara
Organization Doshisha University
Division name Faculty of Health and Sports Science
Zip code 610-0394
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-7531
Homepage URL
Email twakahar@mail.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

Funding Source
Organization MTG 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 Doshisha University
Address Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto
Tel 075-251-3158
Email ji-rinri@mail.doshisha.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
2017 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31721812
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
2016 Year 11 Month 25 Day
Date of IRB
2017 Year 01 Month 06 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2018 Year 12 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
2017 Year 02 Month 07 Day
Last modified on
2019 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029914

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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