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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name