UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035325 |
|---|---|
| Receipt number | R000040250 |
| Scientific Title | Elucidation of the efficacy and mechanism of resistance exercise in nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2018/12/21 |
| Last modified on | 2018/12/20 16:24:19 |
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Basic information
Public title
Elucidation of the efficacy and mechanism of resistance exercise in nonalcoholic fatty liver disease
Acronym
Effect of resistance exercise on nonalcoholic fatty liver disease
Scientific Title
Elucidation of the efficacy and mechanism of resistance exercise in nonalcoholic fatty liver disease
Scientific Title:Acronym
Effect of resistance exercise on nonalcoholic fatty liver disease
Region
| Japan |
Condition
Condition
Nonalchoholic fatty liver disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of resistance exercise on the disease parameters of nonalcoholic fatty liver disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease parameters of nonalcoholic fatty liver disease
Key secondary outcomes
Body composition
Liver fat content
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Resistance exercise
Interventions/Control_2
Education dietary restrictions and encourage to participate in regular physical activities
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nonalcoholic fatty liver disease
Key exclusion criteria
1 Patients with
Comorbidity with poor control
Liver and Renal Failure
Heart and lung disease
Bone and Joint disease
Acute infection
2 Patients determined to be inappropriate by physician
3 Patients who can not take written informed consent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Takahashi |
Organization
Fukushima Medical University
Division name
Gastroenterology
Zip code
Address
1 Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan
TEL
+81-24-547-1202
junior@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Takahashi |
Organization
Fukushima Medical University
Division name
Gastroenterology
Zip code
Address
1 Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan
TEL
+81-24-547-1202
Homepage URL
junior@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
| 2018 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Compared to control group, fat-free mass and muscle mass significantly increased, whereas hepatic steatosis grade, mean insulin and ferritin levels, and the homeostasis model assessment-estimated insulin resistance index were significantly decreased in the exercise group. Compliance with the resistance exercise program did not significantly correlate with patient background characteristics such as age, sex, BMI and metabolic complications.
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
Main results already published
Date of protocol fixation
| 2011 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 31 | 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 | 12 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040250
