UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040680 |
|---|---|
| Receipt number | R000046430 |
| 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 |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2021/06/27 21:37:41 |
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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
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
19mr11@g.seirei.ac.jp
Sponsor or person
Institute
Seirei Sakura Citizen Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046430
