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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020126
Receipt No. 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

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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
Email 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
Email hioki.maya@c.mbox.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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