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
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
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
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
