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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014196
Receipt No. R000014288
Scientific Title Safety and efficacy of neuromuscular electrical stimulation for inpatients with cardiovascular disease
Date of disclosure of the study information 2014/06/07
Last modified on 2016/12/01

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Basic information
Public title Safety and efficacy of neuromuscular electrical stimulation for inpatients with cardiovascular disease
Acronym Safety and efficacy of neuromuscular electrical stimulation for inpatients with cardiovascular disease
Scientific Title Safety and efficacy of neuromuscular electrical stimulation for inpatients with cardiovascular disease
Scientific Title:Acronym 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
1st name
Middle name
Last name TANAKA SHINYA
Organization Kitasato University
Division name Graduate School of Medical Sciences
Zip code
Address 1-15-1, kitasato, minami-ku, sagamiharashi, kanagawa
TEL 042-778-9081
Email tanashin.pt@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name TANAKA SHINYA
Organization Kitasato University
Division name Graduate School of Medical Sciences
Zip code
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)

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
2014 Year 06 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/ihj/advpub/0/advpub_15-493/_article
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 10 Month 30 Day
Date of IRB
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

Other
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

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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