UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033419 |
|---|---|
| Receipt number | R000034786 |
| Scientific Title | Efficacy of resistance training with non-alcoholic fatty liver disease, Randomized control study. |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2020/01/24 10:07:32 |
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Basic information
Public title
Efficacy of resistance training with non-alcoholic fatty liver disease, Randomized control study.
Acronym
Efficacy of resistance training with non-alcoholic fatty liver disease, Randomized control study.
Scientific Title
Efficacy of resistance training with non-alcoholic fatty liver disease, Randomized control study.
Scientific Title:Acronym
Efficacy of resistance training with non-alcoholic fatty liver disease, Randomized control study.
Region
| Japan |
Condition
Condition
fatty liver disease (exclude alcoholic hepatitis)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Western lifestyle provokes metabolic syndrome and non-alcoholic fatty liver disease (NAFLD). NAFLD requires management of diet and exercise therapy. Decreased body mass improves liver steatosis and fibrosis levels. On the other hand, method of exercise is unclear. Since many NAFLD patients with advanced fibrosis present sarcopenia, the efficacy of resistance training must be evaluated urgently. The purpose of this study is to explore how aerobic exercise and resistance training not only increases muscle strength but also improves AST and ALT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of ALT comparing between before and after intervention.
Key secondary outcomes
Laboratory data, Body composition analysis (BIA method), amount of physical exertion (activity meter), Specific Activity Scale, Athens Insomnia Scale.
Concurrently, the efficacy of exercise is also studied in non-intervention group (the evaluation items are the same as above).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Resistance training
Interventions/Control_2
4 month
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as fatty liver
2. ALT >= 40
3. Aged over 20 years old and under 75
4. PS 0 - 1 (ECOG)
5. Patients who are able to provide written consent to participate in this research in person, follow instructions during participation in this research, and undergo protocol-specified physical examination and other examinations.
Key exclusion criteria
Decompensated cirrhosis, Affected malignant tumor in 2-years (exclude carcinoma in situ), heart and lung disease (NYHA > II), percutaneous coronary intervention in 6 month, proliferative diabetic retinopathy, diabetic patient using sulfonylurea / insulin, diabetic neuropathy, severe musculoskeletal impairment, gestation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Okajima Akira |
Organization
Takeda hospital
Division name
Gastroenterology and hepatology
Zip code
Address
841-5, higashiko-ji cho, simogyo-ku, Kyoto, 600-8558
TEL
+81-75-361-1351
aokajima@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Okajima Akira |
Organization
Takeda hospital
Division name
Gastroenterology and hepatology
Zip code
Address
841-5, higashiko-ji cho, simogyo-ku, Kyoto, 600-8558
TEL
+81-75-361-1351
Homepage URL
aokajima@koto.kpu-m.ac.jp
Sponsor or person
Institute
Takeda hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
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
武田病院 / Takeda hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 17 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034786
| 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 |
