UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038629
Receipt number R000043840
Scientific Title Influence of intradialytic aerobic exercise intensity on efficacy of solute removal from small to large molecular weight substances during hemodialysis in maintenance hemodialysis patient: open label controlled trial.
Date of disclosure of the study information 2019/11/22
Last modified on 2021/05/11 09:05:30

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Basic information

Public title

Influence of intradialytic aerobic exercise intensity on efficacy of solute removal from small to large molecular weight substances during hemodialysis in maintenance hemodialysis patient: open label controlled trial.

Acronym

Influence of intradialytic aerobic exercise intensity on solute molecular substances removal during hemodialysis in maintenance hemodialysis patient.

Scientific Title

Influence of intradialytic aerobic exercise intensity on efficacy of solute removal from small to large molecular weight substances during hemodialysis in maintenance hemodialysis patient: open label controlled trial.

Scientific Title:Acronym

Influence of intradialytic aerobic exercise intensity on solute molecular substances removal during hemodialysis in maintenance hemodialysis patient.

Region

Japan


Condition

Condition

end stage renal disease (hemodialysis)

Classification by specialty

Nephrology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study clarifies the difference in the solute removal amount from small to large molecular weight substances during dialysis between two different intradialytic exercise intensity conditions based on anaerobic threshold.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Removal amount of urea nitrogen, phosphate and potassium

Key secondary outcomes

Removal amount of beta2-microglobulin, alpha1-microglobulin and albumin, and circulating blood volume change


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Exercise interventions1: Sixty minutes low-intensity intradialytic aerobic exercise in supine position.

Interventions/Control_2

Exercise interventions2: Sixty minutes medium-intensity intradialytic aerobic exercise in supine position.

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

1.Stable medical condition
2.Stable dialysis hemodynamics
3.Walking independence
4.More than half years after introduction of dialysis
5.Meeting the dialysis conditions of this study: online hemodiafiltration, pre-dilution, 4hours dialysis time, blood flow 250mL/min, total dialysate flow rate 650mL/min, 40L replacement fluid volume, uniform water removal rate, dialysate calcium concentration 2.75mEq/L, polysulfone membrane.

Key exclusion criteria

1.Cardiopulmonary exercise test cannot be performed because it is not possible to ride the sitting position ergometer
2.Untreated heart disease
3.Chronic obstructive pulmonary disease
4.Cerebral infarction sequelae
5.Disagreement with the study participation

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Akimi
Middle name
Last name Uehata

Organization

Kisen hospital

Division name

Department of cardiology

Zip code

125-0041

Address

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

TEL

03-3600-9001

Email

uehata@kisen.or.jp


Public contact

Name of contact person

1st name Naoto
Middle name
Last name Usui

Organization

Kisen hospital

Division name

Department of rehabilitation

Zip code

125-0041

Address

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

TEL

03-3600-9001

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

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kisen hospital

Address

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

Tel

03-3600-9001

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)


Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 22 Day


Related information

URL releasing protocol

NA

Publication of results

Partially published


Result

URL related to results and publications

NA

Number of participants that the trial has enrolled

21

Results

Low-intensity intradialytic exercise improved the removal amount of small molecules and some medium molecules without causing albumin loss.
On the other hand, medium-intensity exercise improved the removal of some solute molecules, but decreased the removal of small molecules after exercise.

Results date posted

2019 Year 11 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

maintenance hemodialysis patients

Participant flow

In advance, participants underwent cardiopulmonary exercise test and measured anaerobic threshold. We classified them into a low-intensity group whose intensity is below the anaerobic threshold and a medium-intensity group whose intensity is above the anaerobic threshold, and they performed intradialytic exercise of each intensity.

Adverse events

Nothing

Outcome measures

Removal amount of urea nitrogen, phosphate ,potassium, beta2-microglobulin, alpha1-microglobulin and albumin.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 07 Month 25 Day

Date of IRB

2016 Year 10 Month 17 Day

Anticipated trial start date

2016 Year 09 Month 30 Day

Last follow-up date

2020 Year 07 Month 13 Day

Date of closure to data entry

2020 Year 07 Month 15 Day

Date trial data considered complete

2020 Year 07 Month 16 Day

Date analysis concluded

2020 Year 07 Month 27 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 19 Day

Last modified on

2021 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043840


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/09/29 data.xlsx