UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022901 |
|---|---|
| Receipt number | R000026339 |
| Scientific Title | Therapeutic Effects of the Exercise Modalities on Hepatic Fat Content and Stiffness for the Management of Nonalcoholic Fatty Liver Disease |
| Date of disclosure of the study information | 2016/06/28 |
| Last modified on | 2016/06/27 12:26:02 |
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Basic information
Public title
Therapeutic Effects of the Exercise Modalities on Hepatic Fat Content and Stiffness for the Management of Nonalcoholic Fatty Liver Disease
Acronym
Effects of Exercise on Nonalcoholic Fatty Liver Disease
Scientific Title
Therapeutic Effects of the Exercise Modalities on Hepatic Fat Content and Stiffness for the Management of Nonalcoholic Fatty Liver Disease
Scientific Title:Acronym
Effects of Exercise on Nonalcoholic Fatty Liver Disease
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish evidence for the most appropriate modality, intensity, time, and duration of exercise for the management of nonalcoholic fatty liver disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hepatic fat content and stiffness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Resistance training
Interventions/Control_2
Moderate-intensity continuous aerobic training
Interventions/Control_3
High-intensity interval aerobic training
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Obesity (BMI > 25)
2) Sedentary (<=1 session per week and <=30 min per session)
3) Subjects with non alcoholic fatty liver disease
Key exclusion criteria
1) Subjects without serious major heart problems
2) Subjects who can not take written informed consent
3) Subjects determined to be inappropriate by physician
4) Subjects who did not receive allocated intervention
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Shoda |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
+81-29-853-5795
shodaj@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Shoda |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
+81-29-853-5795
Homepage URL
shodaj@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 06 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 22 | 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
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026339
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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