UMIN-CTR Clinical Trial

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