UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009350
Receipt No. R000010982
Scientific Title The Effects of neuromuscular electrical stimulation in patients with acute heart failure: a pilot quasi randomized trial.
Date of disclosure of the study information 2012/11/17
Last modified on 2014/05/17

* 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 The Effects of neuromuscular electrical stimulation in patients with acute heart failure: a pilot quasi randomized trial.
Acronym The Effects of neuromuscular electrical stimulation in patients with acute heart failure
Scientific Title The Effects of neuromuscular electrical stimulation in patients with acute heart failure: a pilot quasi randomized trial.
Scientific Title:Acronym The Effects of neuromuscular electrical stimulation in patients with acute heart failure
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this early-phase, pilot quasi randomized clinical trial is to investigate the feasibility and possible effects of neuromuscular electrical stimulation in patients with acute heart failure during inpatient rehabilitation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes maximum voluntary isometric knee extension force
Key secondary outcomes Lower Muscle Mass,Self-Rating Depression Scale, SF-36

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom Maneuver
Interventions/Control_1 neuromuscular electrical stimulation(30 minutes per day, 6 days a week, for 4 weeks) and Aerobic exercise (30 minutes per day, 6 days a week, for 4 weeks)
Interventions/Control_2 Aerobic exercise (30 minutes per day, 6 days a week, for 4 weeks)
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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshida Yosuke
Organization YamatoKashihara Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 81, Isikawa-cho, Kashihara-shi, Nara
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization YamatoKashihara Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute YamatoKashihara Hospital
Institute
Department

Funding Source
Organization Kio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kio University
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
2012 Year 11 Month 17 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 Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 18 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 17 Day
Last modified on
2014 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.