UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Therapeutic Effects of the Exercise Modalities on Hepatic Fat Content and Stiffness for the Management of Nonalcoholic Fatty Liver Disease
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Junichi Shoda
Organization	University of Tsukuba
Division name	Faculty of Medicine
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	Junichi Shoda
Organization	University of Tsukuba
Division name	Faculty of Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 19 Day
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

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Publication of results	Unpublished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