UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029149 |
|---|---|
| Receipt number | R000033332 |
| Scientific Title | Effects of the Belt Electrode Skeletal Muscle Electrical Stimulation on the Leg Extensor strength and the Exercise Tolerance in Healthy Subjects |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2019/07/25 09:32:02 |
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Basic information
Public title
Effects of the Belt Electrode Skeletal Muscle Electrical Stimulation on the Leg Extensor strength and the Exercise Tolerance in Healthy Subjects
Acronym
Effects of the Belt Electrode Skeletal Muscle Electrical Stimulation on the Leg Extensor strength and the Exercise Tolerance in Healthy Subjects
Scientific Title
Effects of the Belt Electrode Skeletal Muscle Electrical Stimulation on the Leg Extensor strength and the Exercise Tolerance in Healthy Subjects
Scientific Title:Acronym
Effects of the Belt Electrode Skeletal Muscle Electrical Stimulation on the Leg Extensor strength and the Exercise Tolerance in Healthy Subjects
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of the belt electrode skeletal muscle electrical stimulation on the leg extensor strength and the exercise tolerance in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quadriceps Femoris Muscle Thickness
Leg extensor strength
Exercise tolerance
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Belt electrode skeletal muscle electrical stimulation
(20 minutes a day, 3 times a week for a total of 6 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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adults
Agree to the full study protocol.
Key exclusion criteria
no orthopedic problem
Subjects with cardiac pacemaker
Subjects with hypersensitivity for electrical stimulation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Fujino |
Organization
Saitama Medical University International Medical Center
Division name
Department of Rehabilitation
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4367
yujifuji@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Fujino |
Organization
Saitama Medical University International Medical Center
Division name
Department of Rehabilitation
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4367
Homepage URL
yujifuji@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
Tel
042-984-4111
chikens@saitama-med.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 | 09 | 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
9
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 | 09 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033332
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
