UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035325
Receipt number R000040250
Scientific Title Elucidation of the efficacy and mechanism of resistance exercise in nonalcoholic fatty liver disease
Date of disclosure of the study information 2018/12/21
Last modified on 2018/12/20 16:24:19

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Basic information

Public title

Elucidation of the efficacy and mechanism of resistance exercise in nonalcoholic fatty liver disease

Acronym

Effect of resistance exercise on nonalcoholic fatty liver disease

Scientific Title

Elucidation of the efficacy and mechanism of resistance exercise in nonalcoholic fatty liver disease

Scientific Title:Acronym

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

1st name
Middle name
Last name Atsushi Takahashi

Organization

Fukushima Medical University

Division name

Gastroenterology

Zip code


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

1st name
Middle name
Last name Atsushi Takahashi

Organization

Fukushima Medical University

Division name

Gastroenterology

Zip code


Address

1 Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan

TEL

+81-24-547-1202

Homepage URL


Email

junior@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



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)



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

2018 Year 12 Month 21 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


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.

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

Main results already published

Date of protocol fixation

2011 Year 12 Month 22 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040250


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name