UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019778 |
|---|---|
| Receipt number | R000022841 |
| Scientific Title | The impact of exercise in hemoialysys patients. |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2015/11/13 13:44:50 |
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Basic information
Public title
The impact of exercise in hemoialysys patients.
Acronym
The impact of exercise in hemoialysys patients.
Scientific Title
The impact of exercise in hemoialysys patients.
Scientific Title:Acronym
The impact of exercise in hemoialysys patients.
Region
| Japan |
Condition
Condition
dialysis patients
Classification by specialty
| Nephrology | Rehabilitation medicine | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We try to improve ADL and QOL hemodialysis patients to take excercise on hemodialysis time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ADL functiional Independence Measure after six monthes exercise(FIM)
Key secondary outcomes
Blood test,CTR,blood pressure
:before exercise,after1,2,3,4,5,6 month
ABI,SPP,POCKET LDF,Critline,QOL(RAND SF36),International Physical Activity Questionnaire:IPAQ,exercise tolerance:METs,AT,RPE,valance:M-FRT(Modified Functional Reach Test),TUG(Timed"Up and Go"test)
:before,3,6month
dialysis efficiency:rejection dose,rejection ratio(UN,Cr,IP,b2-MG,a1-MG,albumin)
:before,after
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
| Other |
Interventions/Control_1
Excercise on hemodialysis
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Dialysis patients with low ADL.
Key exclusion criteria
leg amputation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatori Yuji |
Organization
Rijinkai Medical Foundation Socio-Medical Corporation Kohsei General Hospital
Division name
Internal medicine
Zip code
Address
2-5-1 Enichi-cho,Mihara-shi.Hiroshima-ken, Japan
TEL
0848-63-5500
takatori@rijinkai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatori Yuji |
Organization
Rijinkai Medical Foundation Socio-Medical Corporation Kohsei General Hospital
Division name
Internal medicine
Zip code
Address
2-5-1 Enichi-cho,Mihara-shi.Hiroshima-ken, Japan
TEL
0848-63-5500
Homepage URL
takatori@rijinkai.or.jp
Sponsor or person
Institute
Rijinkai Medical Foundation Socio-Medical Corporation Kohsei General 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 | 12 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 13 | Day |
Last modified on
| 2015 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022841
