UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients
Acronym	The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients
Scientific Title	The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients
Scientific Title:Acronym	The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients
Region	Japan

Condition
Condition	hemodialysis patients
Classification by specialty	Medicine in general Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will examine the effects of physical therapy on hemodialysis patients and identify the factors that influence them.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in physical function (SPPB, grip strength), ADL evaluation (questionnaire method), and clinical parameters of blood sampling (nutrition, oxidative stress) at six and twelve months after the start of physical therapy.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	physical therapy during each dialysis session
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	dialysis patients who visit our outpatient clinic and have given written consent to physical therapy during hemodialysis at our hospital
Key exclusion criteria	Patients with contraindications to physical therapy
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Ino
Organization	toda central general hospital
Division name	Department of Nephrology
Zip code	335-0023
Address	1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
TEL	0484421111
Email	pikkun46@hotmail.com

Public contact
Name of contact person	1st name Jun Middle name Last name Ino
Organization	Toda Central General Hospital
Division name	Department of Nephrology
Zip code	335-0023
Address	1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
TEL	335-0023
Homepage URL
Email	pikkun46@hotmail.com

Sponsor
Institute	Toda Central General Hospital
Institute
Department

Funding Source
Organization	none
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	Ethics Committee of Toda Central General Hospital
Address	1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
Tel	0484421111
Email	pikkun46@hotmail.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 15 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
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	Open public recruiting
Date of protocol fixation	2021 Year 07 Month 01 Day
Date of IRB	2021 Year 07 Month 15 Day
Anticipated trial start date	2021 Year 10 Month 14 Day
Last follow-up date	2023 Year 04 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 11 Day
Last modified on	2021 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052190