UMIN-CTR Clinical Trial

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
Email	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
Email	jin.jiayi.t6@dc.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046454