UMIN-CTR Clinical Trial

Basic information
Public title	Study for the usefulness of exercise by electrical muscle stimulation device in patients with fatty liver
Acronym	Exercise by electrical muscle stimulation
Scientific Title	Study for the usefulness of exercise by electrical muscle stimulation device in patients with fatty liver
Scientific Title:Acronym	Exercise by electrical muscle stimulation
Region	Japan

Condition
Condition	Patients with fatty liver
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the usefulness of excise by electrical muscle stimulation device in patients with fatty liver.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serological indicators (ALT, AST, GGT) and NAFLD scoring system in abdominal ultrasound at 12 weeks after initiation of EMS exercise
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Exercise by EMS device for 12 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient diagnosed as fatty liver by abdominal ultrasonography with no drinking history.
Key exclusion criteria	1) Patients who can not affix the EMS device to their lower limbs 2) Pregnancy, nursing woman or possibly pregnant woman 3) Patients wearing implantable medical electrical equipment such as pacemakers 4) Patient wearing life support electrical equipment such as heart-lung machine 5) Patient wearing medical-type electrical equipment such as electrocardiograph 6) Patients with metal deposits on the body such as a tattoo 7) Patients with history of epilepsy or neurological disorder 8) Patients diagnosed with viral hepatitis 9) Patients diagnosed with autoimmune liver disease 10) Patients diagnosed with drug-induced liver injury 11) Patients with malignant tumors 12) Patients receiving medication to treat fatty liver 13) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Tomoaki Middle name Last name TOMIYA
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Zip code	350-0495
Address	38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL	049-276-1198
Email	tomiya@saitama-med.ac.jp

Public contact
Name of contact person	1st name Yoshihito Middle name Last name UCHIDA
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Zip code	350-0495
Address	38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL	049-276-1198
Homepage URL
Email	y_uchida@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Toray International, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Institutional Review Board of Saitama Medical University Hospital
Address	38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
Tel	049-276-1354
Email	hirb@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	埼玉医科大学病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 10 Day

Related information
URL releasing protocol	unpublished
Publication of results	Unpublished

Result
URL related to results and publications	unpublished
Number of participants that the trial has enrolled	5
Results	Unpublished
Results date posted	2020 Year 07 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Unpublished
Participant flow	Unpublished
Adverse events	Unpublished
Outcome measures	Unpublished
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 10 Day
Date of IRB	2018 Year 01 Month 10 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 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	2018 Year 01 Month 01 Day
Last modified on	2021 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035001