UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of the activities and physical condition has on the cytokine expression by electrical stimulation
Title of the study (Brief title)	Influence of the activities and physical condition has on the cytokine expression by electrical stimulation
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploratory study on the relationship between cytokine expression level and physical function by myoelectric electrical stimulation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Expression level of 40 types of cytokines by muscle electrical stimulation: Eotaxin, Eotaxin-2, GCSF, GM-CSF, ICAM-1, IFN-gamma, I-309, IL-1alpha, IL-1beta, IL-2, IL-3, IL-4, IL-6, IL-6sR, IL-7, IL-8, IL-10, IL-11, IL-12p40, IL-12p70, IL-13, IL-15, IL-16, IL-17, IP-10, MCP-1, MCP-2, M-CSF, MIG, MIP-1alpha, MIP-1beta, MIP-1delta, RANTES, TGF-beta1, TNF-alpha, TNF-beta, sTNF RI, sTNF-RII, PDGF-BB, TIMP-2
Key secondary outcomes	knee extension muscle strength, oxygen uptake at rest, peak oxygen uptake

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	Muscle electrical stimulation
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	26 years-old >=
Gender	Male
Key inclusion criteria	To participate in this research, those who can acquire document consent by their free will with sufficient understanding after receiving sufficient explanation and for healthy volunteers aged 20 to 26 when acquiring consent.
Key exclusion criteria	Those who have disorders that are thought to affect metabolism such as heart failure, diabetes, etc., those who are at risk for intervention such as epilepsy, others who have judged that it is inappropriate by the research director, the research sharing person.
Target sample size	5

Research contact person
Name of lead principal investigator	Takahiro Momota
Organization	Fujita Health University
Division name	School of Health Science
Address	1-98 Dengakugakubo,Kutsukake,Tyoake,Aichi,Japan
TEL	+81-562-93-9000
Email	momo@fujita-hu.ac.jp

Public contact
Name of contact person	Takahiro Momota
Organization	Fujita Health University
Division name	School of Health Science
Address	1-98 Dengakugakubo,Kutsukake,Tyoake,Aichi,Japan
TEL	+81-562-93-9000
Homepage URL
Email	momo@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 28 Day
Last modified on	2017 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030183