UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009703
Receipt No. R000011375
Scientific Title Influence of neuromuscular electrical stimulation on respiro-circulatory condition in patients with acute heart failure
Date of disclosure of the study information 2013/01/07
Last modified on 2014/01/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Influence of neuromuscular electrical stimulation on respiro-circulatory condition in patients with acute heart failure
Acronym Influence of neuromuscular electrical stimulation on respiro-circulatory condition in patients with acute heart
Scientific Title Influence of neuromuscular electrical stimulation on respiro-circulatory condition in patients with acute heart failure
Scientific Title:Acronym Influence of neuromuscular electrical stimulation on respiro-circulatory condition in patients with acute heart
Region
Japan

Condition
Condition acute heart failure
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of neuromuscular electrical stimulation on respiro-circulatory condition in patients with acute heart failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes systolic bloodpressure,heart rate,stroke volume,cardiac output,oxygen consumption,respiration quotient
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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
Interventions/Control_2 neuromuscular electrical stimulation
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 and Female
Key inclusion criteria New York Heart Association(NYHA) class3 or 4, left ventricular ejection fractions<40%
Key exclusion criteria Contraindications for electrical stimulation(e.g., a pacemaker,severe sensory deficits), bone and joint desease, neurological disorders with motor paralysis, dementia, inability to give informed consent form.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Yoshida
Organization Yamatokashihara Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 81, Isikawa-cho, Kashihara-shi, Nara
TEL 0744-27-1071
Email fortunatefield@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Yoshida
Organization Yamatokashihara Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 81,Ishikawatyo, Kashihara-city
TEL 0744-27-1071
Homepage URL
Email fortunatefield@yahoo.co.jp

Sponsor
Institute Yamatokashihara Hospital
Institute
Department

Funding Source
Organization Yamatokashihara 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
2013 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 07 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
2013 Year 01 Month 06 Day
Last modified on
2014 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.