UMIN-CTR Clinical Trial

Basic information
Public title	Is there a difference in circulatory response during aerobic exercise in hemodialysis patients: comparison between non-dialysis days and a certain time after dialysis
Acronym	Is there a difference in circulatory response during aerobic exercise in hemodialysis patients: comparison between non-dialysis days and a certain time after dialysis
Scientific Title	Is there a difference in circulatory response during aerobic exercise in hemodialysis patients: comparison between non-dialysis days and a certain time after dialysis
Scientific Title:Acronym	Is there a difference in circulatory response during aerobic exercise in hemodialysis patients: comparison between non-dialysis days and a certain time after dialysis
Region	Japan

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

Objectives
Narrative objectives1	It is clarified that the circulatory dynamics are different from before exercise after a certain period of time after the end of dialysis compared with those on non-dialysis days, and that exercise shows different circulatory responses.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skeletal muscle oxygen saturation, total hemoglobin, heart rate, blood pressure, double product
Key secondary outcomes	Borg index,Visual Analogue Scale

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	Treatment
Type of intervention	Other
Interventions/Control_1	Exercise with the same load on non-dialysis days and 3 hours after completion of dialysis and during dialysis Both conditions 2 times or more Dialysis days exclude Monday or Tuesday Non-dialysis days exclude Monday
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Pre-discharge hemodialysis patients with stable reasons for hospitalization Outpatient hemodialysis patients
Key exclusion criteria	1.Those who have less than 23 points of cognitive function test (MMSE) and have difficulty performing research 2.Patients who have difficulty in exercise due to unstable circulatory dynamics 3.Persons who have difficulty performing bicycle ergo due to musculoskeletal or central nervous system diseases 4.Those who have been hospitalized for cardiovascular disease 5.Those who are using drugs that suppress heart rate, such as beta-blockers 6.Those who could not obtain research consent, those who withdrew consent and wished to discontinue
Target sample size	15

Research contact person
Name of lead principal investigator	1st name YUUYA Middle name Last name MITAKE
Organization	Seirei Sakura Citizen Hospital
Division name	Department of rehabilitation
Zip code	285-8765
Address	2-36 Ebaradai, Sakura City, Chiba Prefecture
TEL	043-486-1151
Email	19mr11@g.seirei.ac.jp

Public contact
Name of contact person	1st name YUUYA Middle name Last name MITAKE
Organization	Seirei Sakura Citizen Hospital
Division name	Department of rehabilitation
Zip code	285-8765
Address	2-36 Ebaradai, Sakura City, Chiba Prefecture
TEL	043-486-1151
Homepage URL
Email	19mr11@g.seirei.ac.jp

Sponsor
Institute	Seirei Sakura Citizen Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Seirei Sakura Citizen Hospital
Address	2-36 Ebaradai, Sakura City, Chiba Prefecture
Tel	043-486-1151
Email	19mr11@g.seirei.ac.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	聖隷佐倉市民病院（千葉県）

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 01 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	2020 Year 04 Month 08 Day
Date of IRB	2020 Year 06 Month 16 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To compare hemodynamics during aerobic exercise for hospitalized hemodialysis patients after a certain time from the end of dialysis and on non-dialysis days.

Management information
Registered date	2020 Year 06 Month 07 Day
Last modified on	2021 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046430