UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036920 |
|---|---|
| Receipt number | 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 17:12:10 |
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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
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
tsu-yoshimura@maebashi.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Maebashi 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
Saiseikai Maebashi Hospital
Address
564-1 Kamishinden, Maebashi, Gunma
Tel
0272526011
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041749
