UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026408 |
|---|---|
| Receipt number | R000030341 |
| Scientific Title | Effect of Belt electrode Skeletal muscle Electrical Stimulation to physical function and psychological fatigue for hemodialysis patients |
| Date of disclosure of the study information | 2017/03/06 |
| Last modified on | 2018/03/07 23:32:43 |
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Basic information
Public title
Effect of Belt electrode Skeletal muscle Electrical Stimulation to physical function and psychological fatigue for hemodialysis patients
Acronym
Effect of Belt electrode Skeletal muscle Electrical Stimulation to physical function and psychological fatigue for hemodialysis patients
Scientific Title
Effect of Belt electrode Skeletal muscle Electrical Stimulation to physical function and psychological fatigue for hemodialysis patients
Scientific Title:Acronym
Effect of Belt electrode Skeletal muscle Electrical Stimulation to physical function and psychological fatigue for hemodialysis patients
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of Belt electrode Skeletal muscle Electrical Stimulation during dialysis on physical functions and psychological fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
grip strength,Knee extension strength,Berg balance scale, chair stand 30,10m walking test,6 minutes walk distance.
Visual Analogue Scale
Profile of Mood States-Brief Form
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Belt electrode Skeletal muscle Electrical Stimulation
1/week,three month
Interventions/Control_2
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hemodialysis Patients
Frailty Patients
Key exclusion criteria
cardiac pace maker
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuta Noguchi |
Organization
Syutaikai Hospital
Division name
Rehabilitation center
Zip code
Address
8-1,Shirokita,Yokkaichi,Mie
TEL
059-354-1771
reha.noguchi.ot@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Noguchi |
Organization
Syutaikai Hospital
Division name
Rehabilitation center
Zip code
Address
8-1,Shirokita,Yokkaichi,Mie
TEL
059-354-1771
Homepage URL
reha.noguchi.ot@gmail.com
Sponsor or person
Institute
Syutaikai 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
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
| 2017 | Year | 03 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
| 2017 | Year | 03 | Month | 05 | Day |
Last modified on
| 2018 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030341
