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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019778
Receipt No. 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

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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
Email 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
Email takatori@rijinkai.or.jp

Sponsor
Institute Rijinkai Medical Foundation Socio-Medical Corporation Kohsei General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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