UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of Electrical skeletal Muscle Stimulation (EMS) with Positron Emission Tomography
Title of the study (Brief title)	Research of Electrical skeletal Muscle Stimulation
Region	Japan

Condition
Condition	adult male
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate muscles of lower limbs with positron emission tomography after strength training and EMS
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	higher FDG-uptake in the muscles of lower limbs with positron emission tomography after strength training and EMS
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
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	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	electrical skeletal muscle stimulation
Interventions/Control_2	strength training of quadriceps
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Male
Key inclusion criteria	who can exercise quadriceps strength or electrical skeletal muscle stimulation
Key exclusion criteria	with diabetes with malignancy with pain at lower limbs with pacemaker with previous injury of lower limbs
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroyuki Shiozawa
Organization	Gunma University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	39-22 syouwamachi3-chome, maebashishi, gunma-ken, JAPAN
TEL	027-220-8269
Email	bdbk40@gmail.com

Public contact
Name of contact person	Hiroyuki Shiozawa
Organization	Gunma University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	39-22 syouwamachi3-chome, maebashishi, gunma-ken, JAPAN
TEL	027-220-8269
Homepage URL
Email	bdbk40@gmail.com

Sponsor
Institute	Department of Orthopaedic Surgery, Gunma University Graduate School
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Orthopaedic Surgery, Gunma University Graduate School
Organization
Division
Category of Funding Organization	Other
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	群馬大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 23 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2015 Year 07 Month 31 Day
Date of closure to data entry	2015 Year 07 Month 31 Day
Date trial data considered complete	2015 Year 07 Month 31 Day
Date analysis concluded	2015 Year 10 Month 30 Day

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

Management information
Registered date	2014 Year 12 Month 14 Day
Last modified on	2016 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017669