UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053263 |
|---|---|
| Receipt number | R000060794 |
| Scientific Title | Effects of rehabilitation on patients with chronic liver disease |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/01/04 16:00:30 |
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Basic information
Public title
Effects of rehabilitation on patients with chronic liver disease
Acronym
Effects of rehabilitation on patients with chronic liver disease
Scientific Title
Effects of rehabilitation on patients with chronic liver disease
Scientific Title:Acronym
Effects of rehabilitation on patients with chronic liver disease
Region
| Japan |
Condition
Condition
patients with chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of rehabilitation on muscle strength, skeletal muscle mass, quality of life, and even prognosis in patients with chronic liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The impact of rehabilitation on the maintenance of independent living using the Barthel Index, a measure of independence.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have received rehabilitation for impairments such as muscle weakness and ADL deterioration caused by chronic liver disease.
Patients who have not undergone rehabilitation and have undergone either muscle strength, skeletal muscle mass measurement, or abdominal CT as a control group.
Key exclusion criteria
Underage Patients
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Honda |
Organization
Nagoya University Hospital
Division name
Gastoenterology and Hepatology
Zip code
466-8550
Address
Tsuruma-sho 65, Showa-ku, Nagoya city, Aichi
TEL
0527442169
y-ishizu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoji |
| Middle name | |
| Last name | Ishizu |
Organization
Nagoya University Hospital
Division name
Gastoenterology and Hepatology
Zip code
466-8550
Address
Tsuruma-sho 65, Showa-ku, Nagoya city, Aichi
TEL
0527442169
Homepage URL
y-ishizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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 Bioethics Committee
Address
Tsuruma-sho 65, Showa-ku, Nagoya city, Aichi
Tel
0527442111
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
| 2024 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060794
| Research Plan | |
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| 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 |
