UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039256 |
|---|---|
| Receipt number | R000044768 |
| Scientific Title | Effects of intensity and duration of intradialytic aerobic exercise on hemodynamics and hemodialysis adequacy: An open-label randomised cross-over clinical trial. |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2021/08/19 09:48:59 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044768
