UMIN-CTR Clinical Trial

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	https://environhealthprevmed.biomedcentral.com/articles/10.1186/s12199-020-00857-6
Publication of results	Published

Result
URL related to results and publications	https://environhealthprevmed.biomedcentral.com/articles/10.1186/s12199-020-00857-6
Number of participants that the trial has enrolled	45
Results	There were no significant changes in all blood and biochemical parameters in the PA non-increase group at the time of follow-up when compared with baseline levels. In the PA increase group, aspartate aminotransferase, alanine aminotransferase, and guanosine triphosphate levels were all significantly lower at follow-up than they were at baseline. Body weight did not change significantly from baseline to follow-up in both groups.
Results date posted	2021 Year 06 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The study included 154 patients aged 20-85 years who attended the outpatient clinic of the Department of Gastroenterology, Osaka Rosai Hospital; could independently perform activities of daily living; and were given no exercise restrictions by their doctors.
Participant flow	The study included 45 patients with NAFLD who underwent follow-up examinations at least 6 months but no later than 1 year after their baseline examinations. The patients were interviewed about their daily activities and exercise habits to determine whether they had engaged in at least 3 METs per day during the previous 6 months; the quantity of PA, expressed in Ex units, was calculated as METs multiplied by hours. Patients who had achieved at least a 1-Ex increase in PA per week compared to baseline at the time of their follow-up interview the PA increase group were compared to those whose PA was the same or lower at the time of follow up the PA non increase group.
Adverse events	non
Outcome measures	Labo data, physical activity, physical function, habitual behaviors
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	2021 Year 06 Month 08 Day

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