UMIN-CTR Clinical Trial

Basic information
Public title	Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Acronym	Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Scientific Title	Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Scientific Title:Acronym	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	1st name Kotaro Middle name Last name IWATSU
Organization	Hirakata kohsai Hospital
Division name	Department of Rehabilitation
Zip code	573-0153
Address	1-2-1 Fujisakahigashi, Hirakata-shi, Osaka, Japan
TEL	09012353312
Email	kotaro.m.iwatsu@gmail.com

Public contact
Name of contact person	1st name Kotaro Middle name Last name IWATSU
Organization	Hirakata kohsai Hospital
Division name	Department of Rehabilitation
Zip code	573-0153
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)

IRB Contact (For public release)
Organization	the Ethics Committee of the Hirakata Kohsai Hospital
Address	1-2-1 Fujisakashigashimachi, Hirakata, Japan
Tel	072-858-8233
Email	hirakoh.circ@gmail.com

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

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	59
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	Completed
Date of protocol fixation	2018 Year 05 Month 10 Day
Date of IRB	2018 Year 07 Month 23 Day
Anticipated trial start date	2018 Year 07 Month 25 Day
Last follow-up date	2019 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 10 Day
Last modified on	2019 Year 12 Month 31 Day

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