UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016408
Receipt number R000019055
Scientific Title Effectiveness of intradialytic electrical muscle stimulation in hemodialysis efficiency indices and physical function
Date of disclosure of the study information 2015/02/01
Last modified on 2015/02/01 14:58:56

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Basic information

Public title

Effectiveness of intradialytic electrical muscle stimulation in hemodialysis efficiency indices and physical function

Acronym

Effectiveness of intradialytic electrical muscle stimulation

Scientific Title

Effectiveness of intradialytic electrical muscle stimulation in hemodialysis efficiency indices and physical function

Scientific Title:Acronym

Effectiveness of intradialytic electrical muscle stimulation

Region

Japan


Condition

Condition

end stage kidney disease

Classification by specialty

Nephrology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to validate effectiveness of intradialytic electrical muscle stimulation on hemodialysis efficiency indices and physical function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficiency of dialysis (Kt/V), Creatinine clearance, Ambulatory ability, Muscle strength

Key secondary outcomes

Phosphorus clearance rate, beta2 MG clearance rate, Muscle oxygen kinetics


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Electrical muscle stimulation (EMS)

Interventions/Control_2

control

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

50 years-old <

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

The inclusion criteria are: being under dialysis for more than 3months, receiving dialysis 3 times per week, for 4 or 4.5hr per treatment, having no problem in arteriovenous fistulas.

Key exclusion criteria

Exclusion criteria includes the following: not adhering to the EMS program, instability in hemodynamic parameters before and during the EMS, having a history of angina pectoris in the last three months, and having any contraindication to EMS.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Kono

Organization

Aichi Medical College

Division name

Rehabilitation

Zip code


Address

519 Ichiba, Kiyosu City, Aichi Pref, JAPAN

TEL

052-409-3311

Email

kohno1209@gmai.com


Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Kono

Organization

Aichi Medical College

Division name

Rehabilitation

Zip code


Address

519 Ichiba, Kiyosu City, Aichi Pref, JAPAN

TEL

052-409-3311

Homepage URL


Email

kohno1209@gmai.com


Sponsor or person

Institute

Aichi Medical Colllege

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 01 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

Preinitiation

Date of protocol fixation

2015 Year 01 Month 25 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 01 Day

Last modified on

2015 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019055


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name