UMIN-CTR Clinical Trial

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
Email	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
Email	takahas2@cc.saga-u.ac.jp

Sponsor
Institute	Saga University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033150