UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026026 |
|---|---|
| Receipt number | 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 10:47:10 |
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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
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
twakahar@mail.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
