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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032935
Receipt No. R000037544
Official scientific title of the study Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Date of disclosure of the study information 2018/06/10
Last modified on 2018/06/10

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Basic information
Official scientific title of the study Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Title of the study (Brief title) Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Region
Japan

Condition
Condition Patients who admitted for acute decompemsated heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of neuromuscular electrical simulation on physical frailty in patients with acute decompensated heart failure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 10-m comfortable walking speed after 2 weeks of neuromuscular electrical stimulation intervention
Key secondary outcomes Hand grip strength and Short Physical Performance Battery score after 2 weeks of neuromuscular electrical stimulation intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In the intervention group, patients receive inpatients cardiac rehabilitation and neuromucular electrical stimulation on the bilateral quadriceps femoris and triceps for 30 minutes, five times a week, for 2 consecutive weeks. The intensities of stimulation is set to induce knee extension and ankle planter flexion.
Interventions/Control_2 The control group was exposed to the same regimen, except that the stimulation did not cause visible or palpable contractions.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All consecutive adult patients who are hospitalized with decompensated heart failure and receive cardiac rehabilitation at Hirakata kohosai Hospital
Key exclusion criteria -Patients who are not able to walk prior to admission
-Patients who are able to walk 10 m at speed of 0.83 m/sec or more
-Patients with psychiatric disease
-Patients who are not able to receive neuromusclar electrical stimulation due to severe dementia, delirium, or agitation
-Patients with peripheral arterial disease
(Fontaine classification III and IV)
-Patients with mechanical circulatory support
-Patients with neuromuscular disease
Target sample size 66

Research contact person
Name of lead principal investigator Kotaro IWATSU
Organization Hirakata kohsai Hospital
Division name Department of Rehabilitation
Address 1-2-1 Fujisakahigashi, Hirakata-shi, Osaka, Japan
TEL 09012353312
Email kotaro.m.iwatsu@gmail.com

Public contact
Name of contact person Kotaro IWATSU
Organization Hirakata kohsai Hospital
Division name Department of Rehabilitation
Address 1-2-1 Fujisakahigashi, Hirakata-shi, Osaka, Japan
TEL 072-858-8233
Homepage URL
Email kotaro.m.iwatsu@gmail.com

Sponsor
Institute Hirakata kohsai Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 国家公務員共済組合連合会枚方公済病院

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 10 Day
Anticipated trial start date
2018 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 10 Day
Last modified on
2018 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037544

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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