UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028450
Receipt number R000032566
Scientific Title The relationship between blood pressure reduction by standing and respiratory muscle
Date of disclosure of the study information 2019/06/30
Last modified on 2019/08/02 12:29:43

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Basic information

Public title

The relationship between blood pressure reduction by standing and respiratory muscle

Acronym

The relationship between blood pressure fluctuation and respiratory muscle

Scientific Title

The relationship between blood pressure reduction by standing and respiratory muscle

Scientific Title:Acronym

The relationship between blood pressure fluctuation and respiratory muscle

Region

Japan


Condition

Condition

Orthostatic hypotension

Classification by specialty

Cardiology Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Relationship between degree of blood pressure change and respiratory muscle thickness

Basic objectives2

Others

Basic objectives -Others

Relationship between respiratory function test value and respiratory muscle thickness

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Respiratory muscle thickness

Key secondary outcomes

Blood pressure fluctuation range


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients and healthy subjects diagnosed by orthostatic stress test at the Kochi Medical School Hospital from 2017 to 2018

Key exclusion criteria

1. Respiratory diseases
2. Medication affecting blood pressure
3. Smoker

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Ichikawa

Organization

Kochi Medical School

Division name

Department of Cardiovascular Control

Zip code

783-8505

Address

Kohasu, Oko-cho, Nankoku-shi, Kochi 783-8505, Japan

TEL

088-880-2587

Email

ichik@kochi-u.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Ichikawa

Organization

Kochi Medical School

Division name

Department of Cardiovascular Control

Zip code

783-8505

Address

Kohasu, Oko-cho, Nankoku-shi, Kochi 783-8505, Japan

TEL

088-880-2587

Homepage URL


Email

ichik@kochi-u.ac.jp


Sponsor or person

Institute

Kochi University

Institute

Department

Personal name



Funding Source

Organization

Kochi University

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

Ethical review board of Kochi Medical School

Address

Kohasu, Oko-cho, Nankoku-shi, Kochi 783-8505, Japan

Tel

088-880-2180

Email

rinri21@kochi-u.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



Other administrative information

Date of disclosure of the study information

2019 Year 06 Month 30 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

Open public recruiting

Date of protocol fixation

2017 Year 07 Month 06 Day

Date of IRB

2019 Year 05 Month 31 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective study


Management information

Registered date

2017 Year 07 Month 31 Day

Last modified on

2019 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name