UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032202 |
|---|---|
| Receipt number | R000036726 |
| Scientific Title | Effects of renal rehabilitation exercise program in patients with end stage renal disease |
| Date of disclosure of the study information | 2018/04/11 |
| Last modified on | 2018/04/11 20:23:20 |
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Basic information
Public title
Effects of renal rehabilitation exercise program in patients with end stage renal disease
Acronym
Effects of renal rehabilitation for end stage renal disease
Scientific Title
Effects of renal rehabilitation exercise program in patients with end stage renal disease
Scientific Title:Acronym
Effects of renal rehabilitation for end stage renal disease
Region
| Japan |
Condition
Condition
CKD stage5
Classification by specialty
| Medicine in general | Nephrology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate and compare the effects of electrical stimulation for lower limbs on muscle strength, dialysis efficiency, and serum inflammatory markers, including cytokine factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
muscle power
Key secondary outcomes
dialysis efficiency, serum phosphorus, biochemical tests in cluding inflammatory markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Subjects underwent electrical stimulation for 1 hour or less during the first half of the HD session twice a week of 12 consecutive weeks.
Interventions/Control_2
They exercised for 1 hour or less during the first half of the HD session twice a week of 12 consecutive weeks on an ergometer load.
Interventions/Control_3
A group that underwent standard hemodialysis treatment without exercise programs
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
| 65 | years-old | < |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects were stable,maintenance hemodialysis patients who underwent outpatient hemodialysis treatment of three times a week
Key exclusion criteria
Acute coronary syndrome, particularly unstable angina and acute myocardial infarction; systolic blood pressure overed 180 mmHg or diastolic blood pressure overed 110 mmHg; and patients who were determined as inappropriate for the study by the attending physician.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misa Miura |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Science
Zip code
Address
4-12-7,Kasuga,TsukubaCity,Ibaraki,Japan
TEL
029-858-9552
m.miura@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misa Miura |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Science
Zip code
Address
4-12-7,Kasuga,TsukubaCity,Ibaraki,Japan
TEL
029-858-9552
Homepage URL
m.miura@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University of Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2011-120-1
Org. issuing International ID_1
Tohoku University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北柏リハビリテーション病院，平山病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 11 | 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
| 2011 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 11 | Day |
Last modified on
| 2018 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036726
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
