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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033419
Receipt No. 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 2018/09/04

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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
Email 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
Email aokajima@koto.kpu-m.ac.jp

Sponsor
Institute Takeda hospital
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 23 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
2018 Year 07 Month 17 Day
Last modified on
2018 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034786

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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