UMIN-CTR Clinical Trial

Basic information
Public title	Approach and effect for QOL improvement by exercise therapy intervention during dialysis
Acronym	Effects of exercise therapy during dialysis
Scientific Title	Approach and effect for QOL improvement by exercise therapy intervention during dialysis
Scientific Title:Acronym	Effects of exercise therapy during dialysis
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Nephrology Rehabilitation medicine Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	ADL maintenance and QOL improvement such as maintenance of lower limb muscle strength and increased activity in daily life through exercise therapy intervention during dialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1.Health-related quality of life
Key secondary outcomes	2.Leg strength 3.Sleep evaluation 4.Behavior transformation stage

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Exercise every hamodialysis
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatient hemodialysis patients who do not have exercise habits and have lower leg muscle strength
Key exclusion criteria	1.Person who cannot walk even if we use welfare tool 2.Unstable cardiovascular disease 3.Person with arteriosclerosis obliterans 4.Patients with lumbar disease such as lumbar spinal canal stenosis and lumbar disc herniation 5.Patients with cognitive impairment
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ai Middle name Last name Horimoto
Organization	Kawashima Hospital
Division name	Artificial dialysis
Zip code	770-0011
Address	1-39Kitasakoichiban-cho, Tokushima city , Tokushima, Japan
TEL	088-631-0110
Email	moonar325@yahoo.co.jp

Public contact
Name of contact person	1st name Ai Middle name Last name Horimoto
Organization	Kawashima Dialysis Clinic
Division name	Artificial dialysis
Zip code	770-0011
Address	1-39 Kitasakoichiban-cho, Tokushima city , Tokushima, Japan
TEL	088-631-0110
Homepage URL
Email	moonar325@yahoo.co.jp

Sponsor
Institute	Kawashima Hospital
Institute
Department

Funding Source
Organization	Kawashima Hospital
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	Kawashima Hospital
Address	1-39 Kitasakoichiban-cho, Tokushima city , Tokushima, Japan
Tel	088-631-0110
Email	sasaka@khg.or.jp

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	川島病院（徳島県）

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 02 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	6
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	Completed
Date of protocol fixation	2019 Year 04 Month 16 Day
Date of IRB	2019 Year 05 Month 27 Day
Anticipated trial start date	2019 Year 09 Month 02 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 02 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043146