UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040618 |
|---|---|
| Receipt number | R000046336 |
| Scientific Title | A study on balance function before and after dialysis in hemodialysis patients |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2022/04/18 20:13:15 |
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Basic information
Public title
A study on balance function before and after dialysis in hemodialysis patients
Acronym
A study on balance function before and after dialysis in hemodialysis patients
Scientific Title
A study on balance function before and after dialysis in hemodialysis patients
Scientific Title:Acronym
A study on balance function before and after dialysis in hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparative study of balance function before and after dialysis treatment
Basic objectives2
Others
Basic objectives -Others
Identify items related to changes in balance function before and after dialysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Static balancing, dynamic balancing
(within 30 minutes before and after dialysis on dialysis day)
Key secondary outcomes
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
| 48 | years-old | <= |
Age-upper limit
| 88 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients with HD who attend our hospital
Key exclusion criteria
Those who are unable to take measurements, those who have difficulty walking, those who use pacemakers, and those who are unable to give their consent to participate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Shirai |
Organization
Niigata Rinko Hospital, Niigata, Japan
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, Niigata, Japan
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
Department of Rehabilitation,Niigata Rinko Hospital, Niigata, Japan
Institute
Department
Personal name
Funding Source
Organization
no
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, Niigata, Japan
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
2005 - 92
Org. issuing International ID_1
Niigata Rinko Hospital, Niigata, Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Niigata Rinko Hospital, Niigata
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 10 | 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
48
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
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 05 | Month | 01 | Day |
Other
Other related information
Now in progress.
Management information
Registered date
| 2020 | Year | 06 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046336
