UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009350 |
|---|---|
| Receipt number | 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 12:03:41 |
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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
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
Sponsor or person
Institute
YamatoKashihara Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010982
