UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035598 |
|---|---|
| Receipt number | R000040561 |
| Scientific Title | Changes of renal blood flow with exercise load. Consideration using ultrasonic inspection equipment |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2021/02/01 18:13:54 |
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Basic information
Public title
Changes of renal blood flow with exercise load.
Consideration using ultrasonic inspection equipment
Acronym
Changes of renal blood flow with exercise load.
Consideration using ultrasonic inspection equipment
Scientific Title
Changes of renal blood flow with exercise load.
Consideration using ultrasonic inspection equipment
Scientific Title:Acronym
Changes of renal blood flow with exercise load.
Consideration using ultrasonic inspection equipment
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure kidney blood flow using ultrasonic examination apparatus and evaluate the effect on kidney blood flow in exercise load
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute and relative change of exercise-related renal blood flow, cardiopulmonary exercise test, multi-purpose muscle function evaluation exercise machine (BIODEX) using ultrasonic inspection equipment
Key secondary outcomes
Cardiac function, blood pressure, heart rate,Renal function, blood test,
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
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Ultrasound device, Cardiopulmonary exercise test
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
healthy person
Key exclusion criteria
1.age below 20 years old or pregnant
2.those who cannot agree to the study
3.inappropriate patients judged by primary or study physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
rehabilitation
Zip code
500-8523
Address
3-23 Hashimoto,Gifu,Gifu 501-8856 Japan
TEL
058-253-8734
yoshitatsu.f@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
rehabilitation
Zip code
500-8523
Address
3-23 Hashimoto,Gifu,Gifu 501-8856 Japan
TEL
058-253-8734
Homepage URL
yoshitatsu.f@gmail.com
Sponsor or person
Institute
Asahi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi University 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
Asahi University Hospital
Address
3-23 Hashimoto,Gifu,Gifu 501-8856 Japan
Tel
058-253-8734
yoshitatsu.f@gmail.com
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
朝日大学病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 24 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 04 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040561
