UMIN-CTR Clinical Trial

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
Email	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
Email	jm-ta-maeda@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052663