UMIN-CTR Clinical Trial

Basic information
Public title	The effects of interval walking training on development of sarcopenia in patients with chronic liver disease.
Acronym	The effects of interval walking training on patients with chronic liver disease.
Scientific Title	The effects of interval walking training on development of sarcopenia in patients with chronic liver disease.
Scientific Title:Acronym	The effects of interval walking training on patients with chronic liver disease.
Region	Japan

Condition
Condition	chronic liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrine surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects of interval walking training on development of sarcopenia in patients with chronic liver disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction ratio of smooth muscle volume per year
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	interval walking training for 6 M
Interventions/Control_2	Control for 6 M
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	In patients with chronic type C hepatitis or compensated cirrhosis and non alcoholic fatty liver disease, who agrees to do interval walking training (interval walking training group) and who does not agree to do interval walking training (control group).
Key exclusion criteria	1.Patient who is not suitable for doing interval walking training. 2.Patient who experienced cardiovascular disease, peripheral circulatory disease or cerebrovascular disease. 3.Patient with HCC
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Kiyohide Middle name Last name Kioka
Organization	Osaka City General Hospital
Division name	Department of Hepatology
Zip code	534-0021
Address	2-13-22 Miyakojima-hondori Miyakojima-ku Osaka 534-0021 JAPAN
TEL	0669291221
Email	ki-kioka@med.osakacity-hp.or.jp

Public contact
1st name of contact person	1st name Kiyohide Middle name Last name Kioka
Organization	Osaka City General Hospital
Division name	Department of Hepatology
Zip code	534-0021
Address	2-13-22 Miyakojima-hondori Miyakojima-ku Osaka 534-0021 JAPAN
TEL	06-6929-1221
Homepage URL
Email	OCGH-NR@osakacity-hp.or.jp

Sponsor
Institute	osaka city
Institute
Department

Funding Source
Organization	self funding
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	Osaka City General Hospital
Address	2-13-22 Miyakojima-hondori Miyakojima-ku Osaka 534-0021 JAPAN
Tel	06-6929-1221
Email	OCGH-NR@osakacity-hp.or.jp

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	2019 Year 04 Month 12 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	Enrolling by invitation
Date of protocol fixation	2019 Year 01 Month 09 Day
Date of IRB	2019 Year 01 Month 09 Day
Anticipated trial start date	2019 Year 01 Month 30 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 12 Day
Last modified on	2019 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041574