UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052787 |
|---|---|
| Receipt number | R000060241 |
| Scientific Title | Elucidating the Mechanisms of Effects of Electrical Stimulation of Skeletal Muscle on Microvascular Function |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2023/11/13 16:30:34 |
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Basic information
Public title
Elucidation of the mechanisms by which electrical stimulation affects microvascular function
Acronym
Effects of electrical stimulation on microvascular function
Scientific Title
Elucidating the Mechanisms of Effects of Electrical Stimulation of Skeletal Muscle on Microvascular Function
Scientific Title:Acronym
Effects of Electrical Stimulation of Skeletal Muscle on Microvascular Function
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects and mechanisms of skeletal muscle electrical stimulation on microvascular function of the gastrocnemius muscle.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microvascular function from before the start to 20 minutes after the end of the electrical stimulation and up to 30 minutes after the end of the stimulation.
Key secondary outcomes
Blood pressure from before the start to 20 minutes after the end of the electrical stimulation and up to 30 minutes after the end of the stimulation.
Heart rate from before the start to 20 minutes after the end of the electrical stimulation and up to 30 minutes after the end of the stimulation.
Hemodynamics of the shallow femoral artery from before the start to 20 minutes after the end of the electrical stimulation and up to 30 minutes after the end of the stimulation.
Stroke volume from before the start to 20 minutes after the end of the electrical stimulation and up to 30 minutes after the end of the stimulation.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical stimulation conditions for 20 minutes under maximum tolerable intensity.
Interventions/Control_2
Electrical stimulation conditions for 20 minutes under very low intensity
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
No history of cardio-metabolic or metabolic diseases.
Adult males who are not on drug therapy.
Adult male not taking supplements.
Adult men who do not have a regular exercise routine.
Key exclusion criteria
Have a history of cardio-metabolic disease or are receiving drug treatment.
Those who have a regular exercise habit (less than 150 minutes of moderate aerobic exercise or less than 75 minutes of high intensity aerobic exercise per week).
Other subjects who are judged to be inappropriate as research subjects by the principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Tamiya |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252574723
tamiya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Tamiya |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252574723
Homepage URL
tamiya@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for Niigata University of Health and Welfare.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
0252574455
rinri@nuhw.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
| 2023 | Year | 11 | Month | 13 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060241
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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