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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040618
Receipt No. 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 2020/12/01

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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
Email 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
Email shiraino9@gmail.com

Sponsor
Institute Department of Rehabilitation,Niigata Rinko Hospital, Niigata, Japan
Institute
Department

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
Email 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
2020 Year 05 Month 21 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
Date trial data considered complete
Date analysis concluded

Other
Other related information Now in progress.

Management information
Registered date
2020 Year 06 Month 01 Day
Last modified on
2020 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046336

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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