UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020126 |
|---|---|
| Receipt number | R000023242 |
| Scientific Title | Early change in intramyocellular lipid (IMCL) contents by electromyostimulation in healthy elderly |
| Date of disclosure of the study information | 2015/12/22 |
| Last modified on | 2016/01/05 10:04:41 |
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Basic information
Public title
Early change in intramyocellular lipid (IMCL) contents by electromyostimulation in healthy elderly
Acronym
Early change in intramyocellular lipid (IMCL) contents by electromyostimulation in healthy elderly
Scientific Title
Early change in intramyocellular lipid (IMCL) contents by electromyostimulation in healthy elderly
Scientific Title:Acronym
Early change in intramyocellular lipid (IMCL) contents by electromyostimulation in healthy elderly
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the early change in intramyocellular lipid (IMCL) contents by electromyostimulation in healthy elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1H magnetic resonance spectroscopy: IMCL content
intervention(electromyostimulation 30min)pre and post-0min
Key secondary outcomes
Biochemical characteristics: Triglyceride, free fatty acid, glucose, insulin
intervention(electromyostimulation 30min)pre and post-0min
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
electromyostimulation
low frequency electromyostimulation (EMS trio300, Ito Co., Ltd), two rubber stimulation surface electrodes (5*9 cm)
Experiment: 30 min*1 time
Exercise: 30 min*3 times, once a week
Interventions/Control_2
non-electromyostimulation
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy elderly volunteers (independent)
Key exclusion criteria
heart disease (myocardial infarction,
angina pectoris, cardiac insufficiency)
cerebrovascular disease (cerebral infarction, haemorrhage)
extreme hypertension (systolic blood pressure /<=180 mmHg; diastolic blood pressure /<=110 mmHg)
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oshida Yoshiharu |
Organization
Nagoya University
Division name
Research center of health, physical fitness and sports
Zip code
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
052-789-3946
oshida@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hioki Maya |
Organization
Graduate School of Medicine, Nagoya University
Division name
Program in Health and Community Medicine
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-741-2111
Homepage URL
hioki.maya@c.mbox.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 12 | Month | 22 | 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
| 2013 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 21 | 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
| 2015 | Year | 12 | Month | 09 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023242
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
