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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035598
Receipt No. 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 2019/09/28

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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
Email 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
Email yoshitatsu.f@gmail.com

Sponsor
Institute Asahi University Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 04 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 19 Day
Last modified on
2019 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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