UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of the efficacy and mechanism of resistance exercise in nonalcoholic fatty liver disease
Title of the study (Brief title)	Effect of resistance exercise on nonalcoholic fatty liver disease
Region	Japan

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

Objectives
Narrative objectives1	To elucidate the effects of resistance exercise on the disease parameters of nonalcoholic fatty liver disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease parameters of nonalcoholic fatty liver disease
Key secondary outcomes	Body composition Liver fat content

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Resistance exercise
Interventions/Control_2	Education dietary restrictions and encourage to participate in regular physical activities
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Nonalcoholic fatty liver disease
Key exclusion criteria	1 Patients with Comorbidity with poor control Liver and Renal Failure Heart and lung disease Bone and Joint disease Acute infection 2 Patients determined to be inappropriate by physician 3 Patients who can not take written informed consent
Target sample size	150

Research contact person
Name of lead principal investigator	Atsushi Takahashi
Organization	Fukushima Medical University
Division name	Gastroenterology
Address	1 Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan
TEL	+81-24-547-1202
Email	junior@fmu.ac.jp

Public contact
Name of contact person	Atsushi Takahashi
Organization	Fukushima Medical University
Division name	Gastroenterology
Address	1 Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan
TEL	+81-24-547-1202
Homepage URL
Email	junior@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Fukushima Medical University
Organization
Division
Category of Funding Organization	Other
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	2018 Year 12 Month 21 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 12 Month 22 Day
Anticipated trial start date	2012 Year 01 Month 31 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	Partially published
URL releasing results
Results	Compared to control group, fat-free mass and muscle mass significantly increased, whereas hepatic steatosis grade, mean insulin and ferritin levels, and the homeostasis model assessment-estimated insulin resistance index were significantly decreased in the exercise group. Compliance with the resistance exercise program did not significantly correlate with patient background characteristics such as age, sex, BMI and metabolic complications.
Other related information

Management information
Registered date	2018 Year 12 Month 20 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040250