UMIN-ICDS 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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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