UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028972 |
|---|---|
| Receipt number | R000033150 |
| Scientific Title | Effect of exercise training with hand ergometer for patients with nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2021/03/06 12:36:20 |
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Basic information
Public title
Effect of exercise training with hand ergometer for patients with nonalcoholic fatty liver disease
Acronym
Upper limb exercise against nonalcoholic fatty
liver disease
Scientific Title
Effect of exercise training with hand ergometer for patients with nonalcoholic fatty liver disease
Scientific Title:Acronym
Upper limb exercise against nonalcoholic fatty
liver disease
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of fatty liver of NAFLD with exercise training with hand ergometer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity of fatty liver evaluated by ultrasonographic examination
Key secondary outcomes
Liver function evaluated by blood test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise training with hand ergometer for 12 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with NAFLD diagnosed with imaging modarities
Key exclusion criteria
Patients with positive HCV, positive HBV, autoimmune hepatitis,PBC, decompensate liver cirrhosis, alcohol drinker (30g/day or more as ethanol amount in male and 20g/day or more in female) or other etiology of liver disease, heart failure, pacemaker,implantable cardioverter defibrillator and other patients who is considered unsuitable for clinical trial by physician in charge.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Takahashi |
Organization
Saga University, Faculty of Medicine
Division name
Metabolism and Hepatology
Zip code
8498501
Address
Nabeshima 5-1-1, Saga City, Japan
TEL
0952342362
takahas2@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Takahashi |
Organization
Saga University, Faculty of Medicine
Division name
Metabolism and Hepatology
Zip code
8498501
Address
Nabeshima 5-1-1, Saga City, Japan
TEL
0952342362
Homepage URL
takahas2@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga 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
Clinical Study Center, Faculty of Medicine, Saga University
Address
Nabeshima 5-1-1 Saga
Tel
0952316511
clinstudycenter@mail.admin.saga-u.ac.jp
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 | 01 | Day |
Related information
URL releasing protocol
https://www.hospital.med.saga-u.ac.jp/chiken/
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
12
Results
In the 12 subjects with NAFLD, lactate threshold (LT) increased after intervention. There was no significant change in liver stiffness and steatosis measured with FibroScan. There was no significant change in ALT and AST.
In the subjects with increasing LT, GGT significantly decreased.
Results date posted
| 2021 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with NAFLD
Participant flow
All patients were involved in the training program.
Adverse events
none
Outcome measures
liver stiffness and steatosis measured with FibroScan.
Blood liver enzymes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033150
| Research Plan | |
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| Registered date | File name |
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