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
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
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
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
