UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047041 |
|---|---|
| Receipt number | R000052663 |
| Scientific Title | Efficacy and safety of electrical muscle stimulation in older hospitalized patients for acute heart failure |
| Date of disclosure of the study information | 2022/03/02 |
| Last modified on | 2022/03/01 07:54:58 |
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Basic information
Public title
Efficacy and safety of electrical muscle stimulation in older hospitalized patients for acute heart failure
Acronym
Efficacy and safety of electrical muscle stimulation in older hospitalized patients for acute heart failure
Scientific Title
Efficacy and safety of electrical muscle stimulation in older hospitalized patients for acute heart failure
Scientific Title:Acronym
Efficacy and safety of electrical muscle stimulation in older hospitalized patients for acute heart failure
Region
| Japan |
Condition
Condition
Older hospitalized for acute heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate of effect on muscle strength due to electrical muscle stimulation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee extension isometric maximal voluntary contraction
Key secondary outcomes
Muscle thickness
Rate of force development
Short Physical Performance Battery
Blood pressure
Heart rate
Saturation of percutaneous oxygen
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Electrical muscle stimulation therapy and exercise therapy
Interventions/Control_2
Exercise therapy
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients in hospitalized for decompensated heart failure(age>64 and NYHA>3)
Key exclusion criteria
Severe dementia
Acute coronary syndrome
Pacemaker inserter
Significant myocardial ischemia during low-intensity exercise
Resting heart rate>120bpm
Acute infective endocarditis
acute pericarditis
Presence of a recent hospitalization for HF <1 month
Severe symptomatic AS
Severe symptomatic mitral stenosis
hypertrophic obstructive cardiomyopathy
Untreated lift-threatening arrhythmia
Severe pulmonary hypertension
Ongoing orthopnea
Requiring high inotropic support
Patient with inadequate oxygenation
Patient with mechanical ventilation
History of aortic dissection
Patient with uncontrolled DM
PAD(Fontaine stage 3 or 4)
Patient undergoing hemodialysis
sCr>3.0mg/dL
Severe anemia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | maeda |
Organization
Kochi Medical School Hospital
Division name
Department of Rehabilitation Center
Zip code
783-8505
Address
Oko-cho Kohasu, Nankoku, Kochi, Japan
TEL
088-880-2490
jm-ta-maeda@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Maeda |
Organization
Kochi Medical School Hospital
Division name
Department of Rehabilitation Center
Zip code
783-8505
Address
Oko-cho Kohasu, Nankoku, Kochi, Japan 783-8505
TEL
088-880-2490
Homepage URL
jm-ta-maeda@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kochi Medical School Hospital
Address
Oko-cho Kohasu, Nankoku, Kochi, Japan
Tel
088-880-2490
jm-ta-maeda@kochi-u.ac.jp
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
| 2022 | Year | 03 | Month | 02 | 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
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052663
