UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028810 |
|---|---|
| Receipt number | R000031454 |
| Scientific Title | Intervention study about the development of the exercise therapy that is effective for life-style related diseases prevention |
| Date of disclosure of the study information | 2017/08/24 |
| Last modified on | 2019/02/28 17:43:42 |
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Basic information
Public title
Intervention study about the development of the exercise therapy that is effective for life-style related diseases prevention
Acronym
Development of the exercise therapy that is effective for life-style related diseases prevention
Scientific Title
Intervention study about the development of the exercise therapy that is effective for life-style related diseases prevention
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroo Matsuse |
Organization
Department of Orthopedics, Kurume University School of Medicine
Division name
Division of Rehabilitation
Zip code
Address
67 asahi-machi, Kurume Fukuoka
TEL
0942-31-7568
matsuse_hiroh@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuki Hashida |
Organization
Department of Orthopedics, Kurume University School of Medicine
Division name
Division of Rehabilitation
Zip code
Address
67 asahi-machi, Kurume Fukuoka
TEL
0942-31-7568
Homepage URL
hashida_ryuki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
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)
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
久留米大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 24 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031454
