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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036268
Receipt No. R000041313
Scientific Title Cost utility analysis of Renal rehabilitation
Date of disclosure of the study information 2019/07/01
Last modified on 2019/10/15

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Basic information
Public title Cost utility analysis of Renal rehabilitation
Acronym Cost utility analysis of Renal rehabilitation
Scientific Title Cost utility analysis of Renal rehabilitation
Scientific Title:Acronym Cost utility analysis of Renal rehabilitation
Region
Japan

Condition
Condition End stage kidney disease on HD
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the cost utility of renal rehabilitation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incremental Cost Effectiveness Ratio based on Quality-Adjusted Life Years (QALY)
Key secondary outcomes Physical function
The incidence ratio of adverse events
Biochemical parameters

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Exercise training for 60 minutes per day, 3 days per week, 20 weeks during hemodialysis
Interventions/Control_2 Usual care
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hemodialysis patients
Key exclusion criteria 1)Patients who can not speak Japanese,Patients who can not read Japanese
2)Patients who participate in other clinical studies
3)Patients not ensured of an adequate dialysis
4)Patients who start hemodialysis for less than 3 months
5)Cognitive dysfunction
6)Orthopedic patients in lower limb
7)unstable angina pectoris
8)Exercise induced severe arrhythmia
9)Patients who judged that the nephrologist in charge is not appropriate
Target sample size 104

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Kohzuki
Organization Tohoku University Graduate School of
Medicine
Division name Department of Internal medicine and rehabilitation science
Zip code 980-8574
Address 1-1, Seiryo-cho, Aoba-ku, Sendai, Miya gi, Japan
TEL 022-717-7351
Email kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Sadami
Middle name
Last name Asano
Organization Tohoku University Graduate School of Medicine
Division name Department of Internal medicine and rehabilitation science
Zip code 980-8574
Address 1-1, Seiryo-cho, Aoba-ku, Sendai, Miya gi, Japan
TEL 022-717-7353
Homepage URL
Email s.asano@mejiro.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Not receive funds
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University Graduate School of Medicine
Address 1-1, Seiryo-cho, Aoba-ku, Sendai, Miya gi, Japan
Tel 022-222-6181
Email med-kenkyo@grp.tohoku.ac.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

Other administrative information
Date of disclosure of the study information
2019 Year 07 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
2018 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2022 Year 08 Month 01 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 03 Month 21 Day
Last modified on
2019 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041313

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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