UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038783 |
|---|---|
| Receipt number | 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 | 2023/12/07 23:39:39 |
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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
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
y-ishizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
18
Results
underanalysis
Results date posted
| 2023 | Year | 12 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with liver cirrhosis and sarcopenia
Participant flow
After exercise program, the changes of walk speed was evaluated.
Adverse events
None
Outcome measures
Walk speed
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer 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
| 2023 | 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=R000044217
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
