UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041523 |
|---|---|
| Receipt number | R000046454 |
| Scientific Title | The effects of skeletal muscle electrical stimulation to autonomic nervous system of healthy people |
| Date of disclosure of the study information | 2020/09/24 |
| Last modified on | 2021/02/24 11:17:19 |
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Basic information
Public title
The effects of skeletal muscle electrical stimulation to autonomic nervous system of healthy people
Acronym
The effects of skeletal muscle electrical stimulation to autonomic nervous system
Scientific Title
The effects of skeletal muscle electrical stimulation to autonomic nervous system of healthy people
Scientific Title:Acronym
The effects of skeletal muscle electrical stimulation to autonomic nervous system
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes in autonomic nervous activity in healthy individuals were studied through the intervention of electrical stimulation of skeletal muscle in healthy individuals and the effects on further circulatory indicators and psychological status
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
autonomic nervous system
Key secondary outcomes
heart rate
systolic blood pressure
diastolic blood pressure
rating perceived exertion
profile of mood states-brief form 2nd edition
fatigue assessment scale
State-Trait Anxiety Inventory Form Y(STAI-Y)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
skeletal muscle electrical stimulation 20 minutes once
Interventions/Control_2
placebo (non-intervention)
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
male and female
aged 20 years old
Key exclusion criteria
people who smoke and drink too much
people who regularly use drugs
people with abnormal heart and lung function
a person who is pregnant and breastfeeding
people with high blood pressure, diabetes,
kidney disease
people with autonomic nervous dysfunction
people with thrombosis
people with perceptual disturbance
people who use implantable electronic devices
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kohzuki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku Sendai
TEL
022-717-7353
kohzuki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | JIAYI |
| Middle name | |
| Last name | JIN |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku Sendai
TEL
080-4209-6615
Homepage URL
jin.jiayi.t6@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
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
Institution Review Board, Graduate School of Medicine, Tohoku University
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
Tel
81-22-717-8007
med-kenkyo@grp.tohoku.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 | 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
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 24 | Day |
Last modified on
| 2021 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046454
| 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 |
