UMIN-CTR Clinical Trial

Basic information
Public title	Effects of intensity and duration of intradialytic aerobic exercise on hemodynamics and hemodialysis adequacy: An open-label randomised cross-over clinical trial.
Acronym	Effects of intensity and duration of intradialytic aerobic exercise on hemodynamics and hemodialysis adequacy: An open-label randomised cross-over clinical trial.
Scientific Title	Effects of intensity and duration of intradialytic aerobic exercise on hemodynamics and hemodialysis adequacy: An open-label randomised cross-over clinical trial.
Scientific Title:Acronym	Effects of intensity and duration of intradialytic aerobic exercise on hemodynamics and hemodialysis adequacy: An open-label randomised cross-over clinical trial.
Region	Japan

Condition
Condition	End stage kidney disease (Maintenance hemodialysis)
Classification by specialty	Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish safe yet effective prescription of intradialytic exercise based on objective data on hemodynamics and dialysis efficiency during dialysis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood volume change rate, Kt / V urea and removal rate of urea and creatinine.
Key secondary outcomes	Serum albumin, serum total protein, serum phosphate, serum potassium, hemoglobin, hematocrit, systolic blood pressure, diastolic blood pressure and heart rate before, after and during exercise.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Other
Interventions/Control_1	Routine dialysis (rest)
Interventions/Control_2	Medium intensity interval aerobic exercise
Interventions/Control_3	Medium intensity aerobic exercise
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Maintenance hemodialysis outpatients with stable medical condition
Key exclusion criteria	1.Untreated heart disease 2.Chronic obstructive pulmonary disease 3.Sequelae of cerebral infarction 4.Unable to exercise bicycle ergometer 5.Disagree with study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Akihito Middle name Last name Inatsu
Organization	Kisen Hospital
Division name	Nephrology
Zip code	125 - 0041
Address	1-35-8 Higashikanamachi, Katsushika-ku, Tokyo
TEL	03-3600-9007
Email	inatsu@kisen.or.jp

Public contact
Name of contact person	1st name Naoto Middle name Last name Usui
Organization	Kisen Hospital
Division name	Rehabilitation
Zip code	125 - 0041
Address	1-35-8 Higashikanamachi, Katsushika-ku, Tokyo
TEL	03-3600-9007
Homepage URL
Email	usui@kisen.or.jp

Sponsor
Institute	Kisen Hospital
Institute
Department

Funding Source
Organization	Kisen Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kisen Hospital Ethics Review Board
Address	1-35-8 Higashikanamachi, Katsushika-ku, Tokyo
Tel	03-3600-9007
Email	tomura@kisen.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	嬉泉病院(東京都)

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	16
Results	In both continuous and interval intradialytic exercise (IDE), the circulating blood volume during exercise decreased compared to rest dialysis sessions, but after exercise, it recovered to the baseline in both IDE conditions. Regarding the dialysis efficiency of small molecules in continuous and interval IDE conditions, there was no change in the amount removed compared to the resting conditions.
Results date posted	2021 Year 07 Month 27 Day
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 12 Month 03 Day
Date of IRB	2020 Year 01 Month 06 Day
Anticipated trial start date	2020 Year 11 Month 20 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry	2021 Year 05 Month 28 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2021 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2020 Year 01 Month 25 Day
Last modified on	2021 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044768