UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029260 |
|---|---|
| Receipt number | R000033445 |
| Scientific Title | Effect of exercise on sarcopenia in patients with covert hepatic encephalopathy |
| Date of disclosure of the study information | 2017/10/05 |
| Last modified on | 2017/09/24 09:55:08 |
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Basic information
Public title
Effect of exercise on sarcopenia in patients with covert hepatic encephalopathy
Acronym
Covert hepatic encephalopathy and exercise
Scientific Title
Effect of exercise on sarcopenia in patients with covert hepatic encephalopathy
Scientific Title:Acronym
Covert hepatic encephalopathy and exercise
Region
| Japan |
Condition
Condition
Covert hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of exercise on sarcopenia in patients with covert hepatic encephalopathy using bioimpedance analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation for sarcopenia
Key secondary outcomes
Clinical time course in baseline characteristics, brain MRI findings and number connection test.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Physical exercise (patients with pharmacotherapy at registration)
In the physical exercise group, we will conduct guidance to study participants at the outpatient nutrition guidance room. We will also instruct them to do exercise with more than 3 metabolic equivalents (Mets) for 60 minutes per day and to do exercise more than 23 Mets per week.
Interventions/Control_2
Standard therapy
Interventions/Control_3
Physical exercise (patients without pharmacotherapy at registration)
In the physical exercise group, we will conduct guidance to study participants at the outpatient nutrition guidance room. We will also instruct them to do exercise with more than 3 metabolic equivalents (Mets) for 60 minutes per day and to do exercise more than 23 Mets per week.
Interventions/Control_4
Standard therapy
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 with covert hepatic encephalopathy with the age of twenty years or older.
Key exclusion criteria
1.Patients with severe depression or psychiatric disorder
2.Patients with severe OHE who are expected to be difficult to participate in this study.
3.Patients with severe underlying diseases or advanced malignancies.
4.Pregnant or lactating female patients
5.Patients who were judged to be inappropriate for the study subjects
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuhei Nishiguchi |
Organization
Hyogo college of medicine
Division name
Division of hepatobliary and pancreatic disease, department of internal medicine
Zip code
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
TEL
0798-45-6111
kantan@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Yoh |
Organization
Hyogo college of medicine
Division name
Division of hepatobliary and pancreatic disease, department of internal medicine
Zip code
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, Japan
TEL
0798-45-6111
Homepage URL
mm2wintwin@yahoo.co.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo college 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
Address
Tel
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
| 2017 | Year | 10 | Month | 05 | 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
| 2017 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 23 | Day |
Last modified on
| 2017 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033445
| 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 |
