UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019023 |
|---|---|
| Receipt number | R000022002 |
| Scientific Title | Effect of exercise rehabilitation for elderly patients on chronic hemodialysis |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2016/03/31 11:57:34 |
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Basic information
Public title
Effect of exercise rehabilitation for elderly patients on chronic hemodialysis
Acronym
Effect of exercise rehabilitation on chronic hemodialysis
Scientific Title
Effect of exercise rehabilitation for elderly patients on chronic hemodialysis
Scientific Title:Acronym
Effect of exercise rehabilitation on chronic hemodialysis
Region
| Japan |
Condition
Condition
kidney failure
Classification by specialty
| Cardiology | Nephrology | Geriatrics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of physical exercise in patients with Kidney Disease on hemodialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower limb muscle strength
Standing Sitting
CS-30(30-sec Chair stand)
WHO/QOL26
Kt/V
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
3-months of physical exercise in hemodialysis patients.
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
60 years old or older.
It has a treatment of chronic hemodialysis.
It has shown understanding to exercise therapy in chronic hemodialysis.
Key exclusion criteria
It has orthopedic disease.
It has internal dysfunctions.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke CHIGIRA |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health Science
Zip code
Address
501 Nakaoorui, Takasakisi, Gunma
TEL
027-352-1291
chigira@takasaki-u.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tukasa yoshimura |
Organization
Kan-etsu Central Hospital
Division name
Dialysis room
Zip code
Address
71 Kitahara, Takasakisi, Gunma
TEL
027-373-5115
Homepage URL
chigira@takasaki-u.co.jp
Sponsor or person
Institute
Kan-etsu Central 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
| 2015 | Year | 09 | Month | 28 | 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
The exercise therapy of between three months for elderly patients of maintenance dialysis, motor function and lower limb muscle strength, QOL was improved.
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 | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 15 | Day |
Last modified on
| 2016 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022002
