UMIN-CTR Clinical Trial

Basic information
Public title	Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients
Acronym	Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients
Scientific Title	Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients
Scientific Title:Acronym	Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients
Region	Japan

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

Objectives
Narrative objectives1	To investigate the mechanism of exercise tolerance improvement effect of skeletal muscle electrical stimulation to the heart disease patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The 6-Min Walk Distance
Key secondary outcomes	Pleiotropic effects on body function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	1)Cardiac rehabilitation program 2)Electrical muscle stimulation
Interventions/Control_2	1)Cardiac rehabilitation program
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who were hospitalized for heart failure 2)65 years of age or older 3)Short Physical Performance Battery score 9 points or less
Key exclusion criteria	1)Patients with pacemaker insertion 2)Dialysis patient 3)Patients with severe orthopedic diseases 4)Patient with walking disturbance 5)Patients who are ineligible by the principal investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shusuke Yagi
Organization	The University of Tokushima Graduate School of Biomedical Sciences
Division name	Department of Cardiovascular Medicine
Zip code
Address	3-18-15 Kuramoto-cho, Tokushima-city, Tokushima
TEL	088-633-7851
Email	syagi@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Koji Nishikawa
Organization	Tokushima University Hospital
Division name	Departments of Rehabilitation
Zip code
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	088-633-9313
Homepage URL
Email	pt8@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Funding Source
Organization	Tokushima University Hospital
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	2016 Year 10 Month 01 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	Preinitiation
Date of protocol fixation	2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 10 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	2016 Year 08 Month 22 Day
Last modified on	2016 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027316

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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