UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036486 |
|---|---|
| Receipt number | R000041574 |
| Scientific Title | The effects of interval walking training on development of sarcopenia in patients with chronic liver disease. |
| Date of disclosure of the study information | 2019/04/12 |
| Last modified on | 2019/04/12 15:24:29 |
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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
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
ki-kioka@med.osakacity-hp.or.jp
Public contact
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
OCGH-NR@osakacity-hp.or.jp
Sponsor or person
Institute
osaka city
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041574
| 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 |
