UMIN-CTR Clinical Trial

Basic information
Public title	Effects of dialysis exercise therapy on physical motor function and quality of life
Acronym	Examination of usefulness of dialysis exercise therapy
Scientific Title	Effects of dialysis exercise therapy on physical motor function and quality of life
Scientific Title:Acronym	Examination of usefulness of dialysis exercise therapy
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Prevention of sarcopenia and frailty in hemodialysis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Changes in physical motor function evaluation, nutritional aspects, and quality of life during a 6-month dialysis exercise therapy intervention. Physical function evaluation is based on grip strength, knee extension strength, toe grip strength, abduction muscle strength, one-leg standing, CS-30, and walking for 6 minutes. Nutritional evaluation is based on dry weight, body size index, upper arm circumference, subcutaneous fat thickness, brachialis muscle circumference, brachialis muscle area, serum albumin, serum creatinine, C-Reactive Protein, cholinesterase, total cholesterol, and HDL cholesterol. Use the Kidney Disease Quality of Life Short Form (KDQOL-SF) for quality of life.
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	Under the observation of medical staff, about 10 minutes of stretching exercise, rubber tube exercise, and bicycle ergometer exercise will be performed for 6 months during dialysis.
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	30 years-old <
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Outpatient hemodialysis patients with low physical risk from exercise during dialysis and consent to the study
Key exclusion criteria	Severe heart failure Severe bone and joint disorders Bedridden and severe dementia If you do not agree with the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name TAKUYA Middle name Last name KAMINO
Organization	Asakayama General Hospital
Division name	Medical Engineering
Zip code	5900018
Address	3-3-16 Imaike-cho, Sakai-ku, Sakai-shi, Osaka
TEL	0722294882
Email	touseki@asakayama.or.jp

Public contact
Name of contact person	1st name TAKUYA Middle name Last name KAMINO
Organization	Asakayama General Hospital
Division name	Medical Engineering
Zip code	5900018
Address	3-3-16 Imaike-cho, Sakai-ku, Sakai-shi, Osaka
TEL	0722294882
Homepage URL
Email	touseki@asakayama.or.jp

Sponsor
Institute	Asakayama General Hospital
Institute
Department

Funding Source
Organization	Asakayama General Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asakayama General Hospital
Address	3-3-16 Imaike-cho, Sakai-ku, Sakai-shi, Osaka
Tel	0722294882
Email	touseki@asakayama.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

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 05 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	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 22 Day
Date of IRB	2016 Year 04 Month 25 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2022 Year 12 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	2021 Year 07 Month 22 Day
Last modified on	2021 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051331