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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035142
Receipt No. R000040057
Scientific Title Study on movement of patients with chronic liver disease
Date of disclosure of the study information 2018/12/20
Last modified on 2018/12/07

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Basic information
Public title Study on movement of patients with chronic liver disease
Acronym Study on movement of patients with chronic liver disease
Scientific Title Study on movement of patients with chronic liver disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo College of Medicine
Division name Internal Medicine Hepatobiliary pancreatitis
Zip code
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
1st name
Middle name
Last name Kazunori Yoh
Organization Hyogo College of Medicine
Division name Internal Medicine Hepatobiliary pancreatitis
Zip code
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)

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 20 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 Open public recruiting
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
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

Other
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

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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