UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036268 |
|---|---|
| Receipt number | 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 10:10:37 |
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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
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
s.asano@mejiro.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
