UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024409 |
|---|---|
| Receipt number | R000028088 |
| Scientific Title | Effects of a Renal Rehabilitation Exercise Program in Elderly Patients with End-Stage Renal Disease: A Controlled Clinical Trial |
| Date of disclosure of the study information | 2016/10/14 |
| Last modified on | 2018/10/16 12:00:38 |
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Basic information
Public title
Effects of a Renal Rehabilitation Exercise Program in Elderly Patients with End-Stage Renal Disease: A Controlled Clinical Trial
Acronym
Effects of an exercise program for elderly
Scientific Title
Effects of a Renal Rehabilitation Exercise Program in Elderly Patients with End-Stage Renal Disease: A Controlled Clinical Trial
Scientific Title:Acronym
Effects of an exercise program for elderly
Region
| Japan |
Condition
Condition
chronic kidney disease of elderly patients
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of an exercise program on the efficacy of dialysis and on functional and biochemical measurements in elderly patients with chronic kidney disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
efficiencyof dialysis, biochemical examination
Key secondary outcomes
exercise tolerance, muscle force, QOL, ADL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Arobic exercise training on a bicycle ergometer within an hour for 2 days each week for 12 weeks. The duration of the exercise depended on their physical condition. Heart rate during exercise was determined by the Karvonen formula, applying 60% of the heart rate reserve and also using 11-13 rating of perceived exertion
Interventions/Control_2
Electrical stimulation group received electrical stimulation of leg extensors within an hour for 2 days each week for 12 weeks
Interventions/Control_3
received no intervention but standard treatment
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients of filling the following all criteria and having ability for agreement were as follows:
1) Chronic kidney disease stage 5
2) 60 years of age or more
Key exclusion criteria
1)Patients of acute coronary syndromes
2)Patients with cariogenic shock or worsening heart failure.
3)Unstable diabetic patients
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misa Miura |
Organization
Tsukuba University of Technology
Division name
Department of Health Science
Zip code
Address
4-12-7, Kasuga, Tsukuba City, Ibaraki prefecture, 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
Department of Health Science
Zip code
Address
4-12-7, Kasuga, Tsukuba City, Ibaraki prefecture, 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
The Ministry of Education, Culture, Sports, Science and Tchnology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tohoku University Graduate school of Medicine
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
北柏リハビリテーション病院、平山病院、あさおクリニック
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
published
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
| 2015 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 14 | Day |
Last modified on
| 2018 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028088
| 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 |
