UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035142
Receipt number 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 13:59:49

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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 or person

Institute

Hyogo College of Medicine Internal Medicine Hepatobiliary pancreatitis

Institute

Department

Personal name



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

Value
https://center6.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