UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032935
Receipt number R000037544
Scientific Title 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 2019/12/31 02:01:41

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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 or person

Institute

Hirakata kohsai Hospital

Institute

Department

Personal name



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

Value
https://center6.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