UMIN-CTR Clinical Trial

Basic information
Public title	Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Acronym	Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Scientific Title	Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Scientific Title:Acronym	Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of neuromuscular electrical stimulation on quadriceps muscle thickness in patients with acute heart failure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quadriceps muscle thickness every week from the start of physical therapy
Key secondary outcomes	Lower leg muscle strength, SPPB, 6MD, grip strength

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom Maneuver
Interventions/Control_1	In addition to regular rehabilitation, neuromuscular electrical stimulation plus voluntary contraction is performed 30 minutes a day, 5 times a week until discharge.
Interventions/Control_2	Implement regular rehabilitation.
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Person who corresponds to Framingham criteria Person who is BNP400pg / ml or more at admission Those who have NYHA III to IV level at admission Person who is under LVEF 40% at admission Person who was able to walk before hospitalization
Key exclusion criteria	Person who is calmed down Those who are operating implanted electrodes such as pacemakers Those who show loss of sensation in the lower limbs Those who have open wounds or skin allergic symptoms at the treatment site A person who explained the purpose of this study and did not obtain written consent from the patient or the representative A person who is judged inappropriate as a subject by the doctor in charge or research director
Target sample size	20

Research contact person
Name of lead principal investigator	1st name yuki Middle name Last name kakimoto
Organization	Otemae Hospital
Division name	Division of physical medicine and rehabilitation
Zip code	540-0008
Address	1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
TEL	06-6941-0484
Email	y.kakimoto29@outlook.com

Public contact
Name of contact person	1st name yuki Middle name Last name kakimoto
Organization	Otemae Hospital
Division name	Clinical Research Center Clinical Trials Office
Zip code	540-0008
Address	1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
TEL	06-6941-0484
Homepage URL
Email	y.kakimoto29@outlook.com

Sponsor
Institute	Otemae Hospital
Institute
Department

Funding Source
Organization	Kio University
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	Otemae Hospital
Address	1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
Tel	06-6941-0484
Email	info@otemae.gr.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	大手前病院(大阪府)

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 15 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	Terminated
Date of protocol fixation	2018 Year 09 Month 18 Day
Date of IRB	2018 Year 09 Month 19 Day
Anticipated trial start date	2018 Year 09 Month 19 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 15 Day
Last modified on	2019 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032120