UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The respiratory and circulation dynamics change during the belt electrode skeletal muscle electrical stimulation in healthy adults
Title of the study (Brief title)	The respiratory and circulation dynamics change during the belt electrode skeletal muscle electrical stimulation in healthy adults
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Cardiology Pneumology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify safety of the belt electrode skeletal muscle electrical stimulation (B-SES); 1) The change of the oxygen uptake, respiratory dynamics, and circulation dynamics during B-SES. 2) The effect of maximum oxygen uptake and anaerobic threshold to those changing.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Respiratory rate, SpO2, pulse, blood pressure, and oxygen uptake during the belt electrode skeletal muscle electrical stimulation.
Key secondary outcomes	The maximum oxygen uptake and anaerobic threshold.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The belt electrode skeletal muscle electrical stimulation for 20 minutes.
Interventions/Control_2
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	35 years-old >=
Gender	Male
Key inclusion criteria	The healthy adults who are affiliated with Jobu hospital for respiratory diseases or graduate school of health sciences in Gunma university and who agreed the participation in this study.
Key exclusion criteria	1) The person who suffer from heart and respiratory disease or any other medical disease. 2) The person who has pain during exercise due to any orthopedic disease. 3) Smoker.
Target sample size	20

Research contact person
Name of lead principal investigator	Daigo Kato
Organization	Jobu hospital for respiratory diseases
Division name	Department of rehabilitation
Address	586-1 Taguchi, Maebashi, Gunma
TEL	027-232-5000
Email	dkato.rpt@gmail.com

Public contact
Name of contact person	Daigo Kato
Organization	Jobu hospital for respiratory diseases
Division name	Department of rehabilitation
Address	586-1 Taguchi, Maebashi, Gunma
TEL	027-232-5000
Homepage URL
Email	dkato.rpt@gmail.com

Sponsor
Institute	Jobu hospital for respiratory diseases
Institute
Department

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

Other related organizations
Co-sponsor	Graduate school of health sciences, Gunma university
Name of secondary funｄer(s)	None

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（群馬）Gunma university 上武呼吸器科内科病院（群馬）Jobu hospital for respiratory diseases

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 04 Month 21 Day
Last modified on	2018 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031044