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
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
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
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
