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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022901
Receipt No. R000026339
Scientific Title Therapeutic Effects of the Exercise Modalities on Hepatic Fat Content and Stiffness for the Management of Nonalcoholic Fatty Liver Disease
Date of disclosure of the study information 2016/06/28
Last modified on 2016/06/27

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Basic information
Public title Therapeutic Effects of the Exercise Modalities on Hepatic Fat Content and Stiffness for the Management of Nonalcoholic Fatty Liver Disease
Acronym Effects of Exercise on Nonalcoholic Fatty Liver Disease
Scientific Title Therapeutic Effects of the Exercise Modalities on Hepatic Fat Content and Stiffness for the Management of Nonalcoholic Fatty Liver Disease
Scientific Title:Acronym Effects of Exercise on Nonalcoholic Fatty Liver Disease
Region
Japan

Condition
Condition Nonalcoholic fatty liver disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish evidence for the most appropriate modality, intensity, time, and duration of exercise for the management of nonalcoholic fatty liver disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hepatic fat content and stiffness
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Resistance training
Interventions/Control_2 Moderate-intensity continuous aerobic training
Interventions/Control_3 High-intensity interval aerobic training
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
30 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria 1) Obesity (BMI > 25)
2) Sedentary (<=1 session per week and <=30 min per session)
3) Subjects with non alcoholic fatty liver disease
Key exclusion criteria 1) Subjects without serious major heart problems
2) Subjects who can not take written informed consent
3) Subjects determined to be inappropriate by physician
4) Subjects who did not receive allocated intervention
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Shoda
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL +81-29-853-5795
Email shodaj@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Shoda
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL +81-29-853-5795
Homepage URL
Email shodaj@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 28 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 Completed
Date of protocol fixation
2014 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 22 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
2016 Year 06 Month 27 Day
Last modified on
2016 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026339

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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