UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037956 |
|---|---|
| Receipt number | R000043264 |
| Scientific Title | Differences in the balance function between hemodialysis patients and non-hemodialysis patients |
| Date of disclosure of the study information | 2019/09/07 |
| Last modified on | 2019/09/07 01:13:42 |
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Basic information
Public title
Differences in the balance function between hemodialysis patients and non-hemodialysis patients
Acronym
Differences in the balance function between hemodialysis patients and non-hemodialysis patients
Scientific Title
Differences in the balance function between hemodialysis patients and non-hemodialysis patients
Scientific Title:Acronym
Differences in the balance function between hemodialysis patients and non-hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients and non-hemodialysis patients
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference and relationship between the balance function of hemodialysis patients and non-hemodialysis patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dynamic balance
Evaluation before dialysis
Key secondary outcomes
Static balance
Leg strength
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with CKD stage 3a-5D
Key exclusion criteria
We excluded the patients who experienced difficulties with walking, had severe respiratory and cardiovascular diseases, and underwent hemodialysis for less than 1 year.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Shirai |
Organization
Niigata Rinko Hospital
Division name
Department of Rehabilitation
Zip code
950-8725
Address
Momoyama-cho 1-114-3, Higashi-ku, Niigata City
TEL
+81-25-274-5331
shiraino9@gmail.com
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Shirai |
Organization
Niigata Rinko Hospital
Division name
Department of Rehabilitation
Zip code
950-8725
Address
Momoyama-cho 1-114-3, Higashi-ku, Niigata City
TEL
+81-25-274-5331
Homepage URL
shiraino9@gmail.com
Sponsor or person
Institute
Niigata Rinko Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata Rinko Hospital
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
Niigata Rinko Hospital
Address
Momoyama-cho 1-114-3, Higashi-ku, Niigata City
Tel
+81-25-274-5331
shiraino9@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
3011 - 75
Org. issuing International ID_1
3011 - 75
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 | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
131
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2019 | Year | 09 | Month | 07 | Day |
Last modified on
| 2019 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043264
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| Registered date | File name |
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