UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012061 |
|---|---|
| Receipt number | R000014101 |
| Scientific Title | The effect of electrical muscle stimulation on physical performance, quality of life, and hormone level in patients with chronic kidney disease |
| Date of disclosure of the study information | 2013/10/17 |
| Last modified on | 2018/10/22 10:01:48 |
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Basic information
Public title
The effect of electrical muscle stimulation on physical performance, quality of life, and hormone level in patients with chronic kidney disease
Acronym
Effect of electrical muscle stimulation in patients with chronic kidney disease
Scientific Title
The effect of electrical muscle stimulation on physical performance, quality of life, and hormone level in patients with chronic kidney disease
Scientific Title:Acronym
Effect of electrical muscle stimulation in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the effect of electrical muscle stimulation in patients with chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower-limb muscle strength
Key secondary outcomes
Muscle cross-sectional area
Balance ability
Quality of life
Blood exam
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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 for 8 weeks
Interventions/Control_2
Electrical muscle stimulation (-)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stage 5 CKD(chronic kidney disease)
Key exclusion criteria
Metallic insertion
Severe heart disease
Dementia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Suzuki |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
rehadoc441124@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Suzuki |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
rehadoc441124@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
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
| 2013 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/?term=Beneficial+effect+of+intradialytic+electrical+muscle+stimu
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
| 2013 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 17 | 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
| 2013 | Year | 10 | Month | 17 | Day |
Last modified on
| 2018 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014101
