UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030656 |
|---|---|
| Receipt number | 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 | 2021/07/21 18:24:49 |
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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 | 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
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
y_uchida@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035001
