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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030656
Receipt No. R000035001
Scientific Title Study for the usefulness of exercise by electrical muscle stimulation device in patients with fatty liver
Date of disclosure of the study information 2018/01/10
Last modified on 2018/11/27

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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
Middle name
Last name Tomoaki TOMIYA
Organization Saitama Medical University
Division name Department of Gastroenterology & Hepatology
Zip code
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
Middle name
Last name Yoshihito UCHIDA
Organization Saitama Medical University
Division name Department of Gastroenterology & Hepatology
Zip code
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
Address
Tel
Email

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
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
2018 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
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
2018 Year 11 Month 27 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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