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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036920
Receipt No. R000041749
Scientific Title Examination for the effects after renal rehabilitation intervention
Date of disclosure of the study information 2019/06/01
Last modified on 2019/06/01

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Basic information
Public title Examination for the effects after renal rehabilitation intervention
Acronym effects after renal rehabilitation intervention
Scientific Title Examination for the effects after renal rehabilitation intervention
Scientific Title:Acronym effects after renal rehabilitation intervention
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Cardiology Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine how the patients are affected by the exercise therapy during the dialysis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3m timed up-and-go
At eye opening single leg rising
SF-36
Kt/V
ankle brachial index
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 Exercise therapy during the dialysis for 2 years
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 60 years old and/or older.
It receives maintenance dialysis.
It shows understanding for the exercise therapy during the dialysis.
Key exclusion criteria It has the orthopedics disease with the trouble for exercise.
It has the internal disorder with the trouble for exercise.
It has the heart disorder with the trouble for exercise.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tsukasa
Middle name
Last name Yoshimura
Organization Saiseikai Maebashi Hospital
Division name Department of Clinical Engineering
Zip code 371-0821
Address 564-1 Kamishinden, Maebashi, Gunma
TEL 0272526011
Email tsu-yoshimura@maebashi.saiseikai.or.jp

Public contact
Name of contact person
1st name Tsukasa
Middle name
Last name Yoshimura
Organization Saiseikai Maebashi Hospital
Division name Department of Clinical Engineering
Zip code 371-0821
Address 564-1 Kamishinden, Maebashi, Gunma
TEL 0272526011
Homepage URL
Email tsu-yoshimura@maebashi.saiseikai.or.jp

Sponsor
Institute Saiseikai Maebashi 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 Saiseikai Maebashi Hospital
Address 564-1 Kamishinden, Maebashi, Gunma
Tel 0272526011
Email tsu-yoshimura@maebashi.saiseikai.or.jp

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 群馬県済生会前橋病院(群馬県)

Other administrative information
Date of disclosure of the study information
2019 Year 06 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 01 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041749

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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