UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046336