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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036757
Receipt No. R000032120
Scientific Title Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Date of disclosure of the study information 2019/05/15
Last modified on 2019/05/15

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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 Enrolling by invitation
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 05 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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