UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037964 |
|---|---|
| Receipt number | R000043274 |
| Scientific Title | Change in muscle activity after farigue of gluteus maximus |
| Date of disclosure of the study information | 2020/09/09 |
| Last modified on | 2021/03/12 10:27:34 |
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Basic information
Public title
Effect of muscle fatigue in buttoks on muscle activity
Acronym
Buttoks fatigue study
Scientific Title
Change in muscle activity after farigue of gluteus maximus
Scientific Title:Acronym
Gluteus maximus fatigue study
Region
| Japan |
Condition
Condition
Healthy men
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the change in muscles activity before and after selective fatigue of gluteus maximum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immediately change in muscle activity pattern
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrostimulation to gluteus maximus for 30 min
Device: Low-frequency treatment devise (ESPURGE, Ito Corp.), Electrical Muscle Stimulation mode
Frequency: 40Hz
Pulse wide: 20 micro-sec
Electric current: 45mA
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 men without orthopaedic desease at trunk or lower limb
Key exclusion criteria
history of operation
history of muscle strain
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Okubo |
Organization
Saitama Medical University
Division name
Faculty of Health and Medical Care
Zip code
350-0496
Address
981, Kawakado, Moroyama-machi, Iruma-gun, Saitama
TEL
049-295-1001
yokubo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Okubo |
Organization
Saitama Medical University
Division name
Faculty of Health and Medical Care
Zip code
350-0496
Address
981, Kawakado, Moroyama-machi, Iruma-gun, Saitama
TEL
049-295-1001
Homepage URL
yokubo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Ethic committee of Saitama Medical University, Faculty of Health and Medical Care
Address
1397-1, Yamane, Hidaka, Saitama
Tel
042-984-4801
yokubo@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
| 2020 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
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
Main results already published
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043274
| 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 |
