UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048885
Receipt number R000055703
Scientific Title Effect of intradialytic aerobic exercise to changes in regional oxygen saturation during hemodialysis.
Date of disclosure of the study information 2022/09/09
Last modified on 2022/09/08 14:07:04

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Basic information

Public title

Effect of intradialytic aerobic exercise to changes in regional oxygen saturation during hemodialysis.

Acronym

Effect of intradialytic aerobic exercise to changes in regional oxygen saturation during hemodialysis.

Scientific Title

Effect of intradialytic aerobic exercise to changes in regional oxygen saturation during hemodialysis.

Scientific Title:Acronym

Effect of intradialytic aerobic exercise to changes in regional oxygen saturation during hemodialysis.

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 reveal effect of intradialytic aerobic exercise to changes in regional oxygen saturation during hemodialysis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

regional oxygen saturation
cerebral oxyhemoglobin
cerebral deoxyhemoglobin
cerebral total hemoglobin

Key secondary outcomes

systolic blood pressure, diastolic blood pressure, heart rate, stroke volume, cardiac output, blood volume change rate, hemoglobin, hematocrit, arterial oxygen tension, arterial carbon dioxide tension, pH, bicarbonate, lactate, sodium, potassium


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Usual care (only dialysis)

Interventions/Control_2

Moderate intensity interval exercise

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

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 Sho
Middle name
Last name Kojima

Organization

Kisen Hospital

Division name

Department of Rehabilitation

Zip code

125 - 0041

Address

1-35-8 Higashikanamachi, Katsushika-ku, Tokyo

TEL

03-3600-9007

Email

usui@kisen.or.jp


Public contact

Name of contact person

1st name Sho
Middle name
Last name Kojima

Organization

Kisen Hospital

Division name

Department of 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 or person

Institute

Kisen Hospital

Institute

Department

Personal name



Funding Source

Organization

Kisen 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

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



Other administrative information

Date of disclosure of the study information

2022 Year 09 Month 09 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 09 Month 01 Day

Date of IRB

2020 Year 09 Month 28 Day

Anticipated trial start date

2022 Year 09 Month 09 Day

Last follow-up date

2023 Year 09 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 09 Month 08 Day

Last modified on

2022 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055703


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name