UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on movement of patients with chronic liver disease
Title of the study (Brief title)	Study on movement of patients with chronic liver disease
Region	Japan

Condition
Condition	Patients with chronic liver disease who are over 20 years old.
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We periodically and quantitatively measure the progress of the original disease and the influence of the treatment using a questionnaire form, an actigraph, and a body composition meter, and examine the relationship between Sarcopenia, ADL and QOL.
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ActiGraph(Change every month)
Key secondary outcomes	A) Questionnaire survey: BDI - II (Beck depressed questionnaire), Pittsburgh Sleep Questionnaire (PSQI), SF - 36 B) Evaluation of Sarcopenia (Change every month)

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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Chronic liver disease patients
Key exclusion criteria	A)Patients with liver disease other than patients with chronic liver disease B) Patients with severe depression or psychoneuropathy C) Patients with severe complications D) Pregnant women, lactating women or women who may be pregnant E) Other studies Patient who the responsible person judged inappropriate as subject of this examination
Target sample size	300

Research contact person
Name of lead principal investigator	Shuhei Nishiguchi
Organization	Hyogo College of Medicine
Division name	Internal Medicine Hepatobiliary pancreatitis
Address	1-1, Mukogawa Town, Nishinomiya-shi Hyogo ken
TEL	0798-45-6472
Email	yo-yo-yo@hyo-med.ac.jp

Public contact
Name of contact person	Kazunori Yoh
Organization	Hyogo College of Medicine
Division name	Internal Medicine Hepatobiliary pancreatitis
Address	1-1, Mukogawa Town, Nishinomiya-shi Hyogo ken
TEL	0798-45-6472
Homepage URL
Email	yo-yo-yo@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine Internal Medicine Hepatobiliary pancreatitis
Institute
Department

Funding Source
Organization	Hyogo College of Medicine Internal Medicine Hepatobiliary pancreatitis
Organization
Division
Category of Funding Organization	Self funding
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 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 01 Day
Anticipated trial start date	2012 Year 11 Month 20 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	Unpublished
URL releasing results
Results
Other related information	Observational research on a single facility. This study is an observational study and is performed using clinical data extracted from the patient's daily medical record and actigraph.

Management information
Registered date	2018 Year 12 Month 05 Day
Last modified on	2018 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040057