UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of neuromuscular electrical stimulation for inpatients with cardiovascular disease
Title of the study (Brief title)	Safety and efficacy of neuromuscular electrical stimulation for inpatients with cardiovascular disease
Region	Japan

Condition
Condition	Cardiovascular disease
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety and efficacy of neuromuscular electrical stimulation for inpatients with cardiovascular disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Vascular endothelial function
Key secondary outcomes	Blood pressure, heart rate, stroke volume, cardiac output, cardiac index, systemic vascular resistance, sympathetic activity, transcutaneous oxygen pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Neuromuscular electrical stimulation of the highest tolerable intensity
Interventions/Control_2	Neuromuscular electrical stimulation of the minimum intensity that did not induce muscle contractions
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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patients with cardiovascular disease are undergoing cardiac rehabilitation
Key exclusion criteria	1.Patients with unstable angina pectoris 2.Patients with uncontrolled decompensated heart failure 3.Patients who used pacemaker 4.Patients who are not allowed to receive neuromuscular electrical stimulation
Target sample size	40

Research contact person
Name of lead principal investigator	TANAKA SHINYA
Organization	Kitasato University
Division name	Graduate School of Medical Sciences
Address	1-15-1, kitasato, minami-ku, sagamiharashi, kanagawa
TEL	042-778-9081
Email	tanashin.pt@gmail.com

Public contact
Name of contact person	TANAKA SHINYA
Organization	Kitasato University
Division name	Graduate School of Medical Sciences
Address	1-15-1, kitasato, minami-ku, sagamiharashi, kanagawa
TEL	042-778-9081
Homepage URL
Email	tanashin.pt@gmail.com

Sponsor
Institute	Graduate School of Medical Sciences, Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
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

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 30 Day
Anticipated trial start date	2013 Year 11 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	Published
URL releasing results	https://www.jstage.jst.go.jp/article/ihj/advpub/0/advpub_15-493/_article
Results
Other related information

Management information
Registered date	2014 Year 06 Month 06 Day
Last modified on	2016 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014288