UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046139 |
|---|---|
| Receipt number | R000051359 |
| Scientific Title | Confirmed of the effect of electrical stimulation of muscle activity on the thigh |
| Date of disclosure of the study information | 2021/11/24 |
| Last modified on | 2024/06/07 19:17:52 |
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Basic information
Public title
Effects of electrical stimulation for the quadriceps
Acronym
Effects of electrical stimulation for the quadriceps
Scientific Title
Confirmed of the effect of electrical stimulation of muscle activity on the thigh
Scientific Title:Acronym
Confirmed of the effect of electrical stimulation of muscle activity on the thigh
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to examine changes in muscle activity in the thigh muscle using electrical stimulation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle strength
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Low frequency electrical stimulation for 8 weeks
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy people
Key exclusion criteria
People who can't exercise
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Takano |
Organization
International University of Health and Welfare
Division name
School of Health Science at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu Okawa Fukuoka
TEL
0944892000
y-takano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Takano |
Organization
International University of Health and Welfare
Division name
School of Health Science at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu Okawa Fukuoka
TEL
0944892000
Homepage URL
y-takano@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Riccoh Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
kurume University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
137-1 Enokizu Okawa Fukuoka
Tel
0944892000
y-takano@iuhw.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
国際医療福祉大学、J-workout、風の谷
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 24 | 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
20
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The paper is in submission.
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
| 2021 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051359
