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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038783
Receipt No. R000044217
Scientific Title Investigation for the effect of home-exercise on cirrhotic patients with sarcopenia
Date of disclosure of the study information 2020/01/01
Last modified on 2020/09/26

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Basic information
Public title Investigation for the effect of home-exercise on cirrhotic patients with sarcopenia
Acronym Exercise for cirrhotic patients with sarcopenia
Scientific Title Investigation for the effect of home-exercise on cirrhotic patients with sarcopenia
Scientific Title:Acronym Investigation for the effect of home-exercise on cirrhotic patients with sarcopenia
Region
Japan

Condition
Condition cirrhotic patients with sarcopenia
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation for the effect of home-exercise on physical function
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gait Speed (4m)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 home-exercise
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

Not applicable
Gender Male and Female
Key inclusion criteria Cirrhotic patients with sarcopenia
Key exclusion criteria Patients with malignancy
Patients with decompensated cirrhosis
Patients with unstable ischemic heart desease
Patients with chronic heart or respiratory failure

Patients who are unable to exercise
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masatoshi
Middle name
Last name Ishigami
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Zip code 466-8550
Address Nagoya city Showa-ku Turuma-sho 65
TEL 0527442169
Email masaishi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Yoji
Middle name
Last name Ishizu
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Zip code 466-8550
Address Nagoya city Showa-ku Turuma-sho 65
TEL 0527442169
Homepage URL
Email y-ishizu@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University Graduate School of Medicine
Address Ethic committee
Tel 0527442973
Email ethics@med.nagoya-u.ac.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
2020 Year 01 Month 01 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
2019 Year 12 Month 03 Day
Date of IRB
2020 Year 01 Month 29 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2022 Year 06 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 12 Month 04 Day
Last modified on
2020 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044217

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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