UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study about the development of the exercise therapy that is effective for life-style related diseases prevention
Title of the study (Brief title)	Development of the exercise therapy that is effective for life-style related diseases prevention
Region	Japan

Condition
Condition	Visceral fat type obesity
Classification by specialty	Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effect of electrical stimulation for physical function, visceral fat, hepatic steatosis,carbohydrate metabolism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	hepatic steatosis,visceral fat
Key secondary outcomes	body weight,BMI,AST,ALT,Carbohydrate metabolism

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	electrical stimulation during walking for 12 weeks
Interventions/Control_2	walking for 12 weeks
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	Visceral fat type obesity
Key exclusion criteria	Diabetes patients with poor control
Target sample size	35

Research contact person
Name of lead principal investigator	Hiroo Matsuse
Organization	Department of Orthopedics, Kurume University School of Medicine
Division name	Division of Rehabilitation
Address	67 asahi-machi, Kurume Fukuoka
TEL	0942-31-7568
Email	matsuse_hiroh@kurume-u.ac.jp

Public contact
Name of contact person	Ryuki Hashida
Organization	Department of Orthopedics, Kurume University School of Medicine
Division name	Division of Rehabilitation
Address	67 asahi-machi, Kurume Fukuoka
TEL	0942-31-7568
Homepage URL
Email	hashida_ryuki@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	久留米大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 24 Day
Last modified on	2019 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031454