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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016408
Receipt No. 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

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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
Institute Aichi Medical Colllege
Institute
Department

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
URL(English) https://upload.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


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