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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038530
Receipt No. R000043289
Scientific Title Influence of physical activity for improvement of hepatic inflammation in patients with nonalcoholic fatty liver disease
Date of disclosure of the study information 2019/11/11
Last modified on 2020/06/05

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Basic information
Public title Influence of physical activity for improvement of hepatic inflammation in patients with nonalcoholic fatty liver disease
Acronym Influence of physical activity in patients with nonalcoholic fatty liver disease
Scientific Title Influence of physical activity for improvement of hepatic inflammation in patients with nonalcoholic fatty liver disease
Scientific Title:Acronym Influence of physical activity in patients with nonalcoholic fatty liver disease
Region
Japan

Condition
Condition nonalcoholic fatty liver disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Non-alcoholic fatty liver disease (NAFLD) is a risk factor for liver cancer. Dietary and exercise therapy is recommended to prevent NAFLD. However, few reports have investigated the effects of physical activity on NAFLD. The purpose of this study is to investigate the effect of PA on inflammation of the liver of patients with NAFLD after paying attention to obesity closely related to NAFLD.

Basic objectives2 Others
Basic objectives -Others Observational research
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes blood biochemical test(AST, ALT, LDH,ALP,T-Bil, TC, TG).
Key secondary outcomes Amount of physical activity, Body weight, body composition(skeletal muscle mass, body fat mass). Total energy intake,smoking habit.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patient diagnosed as nonalcoholic fatty liver disease: NAFLD
2. Informed Consent has been obtained in writing form.by himself / herself about examination participation
Key exclusion criteria 1. Patient who has been infected with hepatitis virus
2. Patient has a clear drinking history (Alcohol amount: over 20 g / day)
3. patient who has difficulties in doing exercise, such as any joint pain, kidney dysfunction or heart disease
4. Patient who was judged as inappropriate for this research by researcher(mental disorder, etc).
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Fuminari
Middle name
Last name Asada
Organization Osaka Rosai Hospital
Division name Research Center for the Promotion of Health and Employment Support
Zip code 591-8025
Address 3-1179,Nagasone-Cho, Kita-Ku, Sakai-City, Osaka 591-8025, Japan
TEL 072-255-7520(4255)
Email f-asada@osakah.johas.go.jp

Public contact
Name of contact person
1st name Fuminari
Middle name
Last name Asada
Organization Osaka Rosai Hospital
Division name Research Center for the Promotion of Health and Employment Support
Zip code 591-8025
Address 3-1179,Nagasone-Cho, Kita-Ku, Sakai-City, Osaka 591-8025, Japan
TEL 072-255-7520
Homepage URL
Email f-asada@osakah.johas.go.jp

Sponsor
Institute Japan Organization of Occupational Health and Safety
Institute
Department

Funding Source
Organization Japan Organization of Occupational Health and Safety
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 Osaka Rosai Hospital
Address 3-1179,Nagasone-Cho, Kita-Ku, Sakai-City, Osaka 591-8025, Japan
Tel 072-255-7520
Email f-asada@osakah.johas.go.jp

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 大阪労災病院

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 11 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
2013 Year 02 Month 01 Day
Date of IRB
2013 Year 02 Month 15 Day
Anticipated trial start date
2013 Year 03 Month 18 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preventive medicine model project.
https://www.johas.go.jp/yobomodel//tabid/987/Default.aspx

Management information
Registered date
2019 Year 11 Month 10 Day
Last modified on
2020 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043289

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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