UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000035325
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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)

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
URL(English) https://upload.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


Contact us.