UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of exercise on sarcopenia in patients with overt hepatic encephalopathy
Title of the study (Brief title)	Exercise and overt hepatic encephalopathy
Region	Japan

Condition
Condition	Overt hepatic encephalopathy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Scarce data are currently available for the effect of exercise on sarcopenia for OHE patients receiving PE. The aims of the current study are to prospectively examine the effect of exercise on sarcopenia in patients with OHE.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Assessment of sarcopenia using BIA
Key secondary outcomes	Clinical time course in baseline characteristics, brain MRI findings and number connection test.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Other
Interventions/Control_1	Physical exercise In the physical exercise group, we will conduct guidance to study participants at the outpatient nutrition guidance room. We will also instruct them to do exercise with more than 3 metabolic equivalents (Mets) for 60 minutes per day and to do exercise more than 23 Mets per week.
Interventions/Control_2	Standard pharmacotherapy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with OHE with the age of twenty years or older receiving pharmacotherapy
Key exclusion criteria	1.Patients with severe depression or psychiatric disorder 2.Patients with severe OHE who are expected to be difficult to participate in this study. 3.Patients with severe underlying diseases or advanced malignancies. 4.Pregnant or lactating female patients 5.Patients who were judged to be inappropriate for the study subjects
Target sample size	40

Research contact person
Name of lead principal investigator	Shuhei Nishiguchi
Organization	Hyogo college of medicine
Division name	Division of hepatopancreatology, department of internal medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
TEL	0798-45-6111
Email	kantan@hyo-med.ac.jp

Public contact
Name of contact person	Kazunori Yoh
Organization	Hyogo college of medicine
Division name	Division of hepatopancreatology, department of internal medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
TEL	0798-45-6111
Homepage URL
Email	mm2wintwin@yahoo.co.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
Organization
Division
Category of Funding Organization	Other
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	2017 Year 10 Month 05 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 17 Day
Anticipated trial start date	2017 Year 10 Month 15 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

Management information
Registered date	2017 Year 09 Month 22 Day
Last modified on	2017 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033396