UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019947
Receipt number R000023035
Scientific Title Evaluation of Diaphragmatic Contractility using the Stimulus Mechanomyogram in the Elderly
Date of disclosure of the study information 2015/11/27
Last modified on 2015/12/21 09:40:49

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Basic information

Public title

Evaluation of Diaphragmatic Contractility using the Stimulus Mechanomyogram in the Elderly

Acronym

Evaluation of Diaphragmatic Contractility

Scientific Title

Evaluation of Diaphragmatic Contractility using the Stimulus Mechanomyogram in the Elderly

Scientific Title:Acronym

Evaluation of Diaphragmatic Contractility

Region

Japan


Condition

Condition

Non

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A purpose is to evaluate of diaphragmatic contractility using the stimulus mechanomyogram in the elderly

Basic objectives2

Others

Basic objectives -Others

evaluation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

measurement of diaphragmatic contractility and spirogram

Key secondary outcomes



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

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

I measure spirogram and diaphragmatic contractility.
The period of service is from 2013 end of July or after approval of ethics committee to 2014 end of August.
The measurement is completed within 1 hour and single trial per one patients.

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

60 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult patients

Key exclusion criteria

Severe respiratory disease

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shogo WATANABE

Organization

Graduate school of health sciences, Okayama university

Division name

Department of Medical Technology

Zip code


Address

2-5-1 sikata-cho kita-ku okayama city, Okayama, Japan

TEL

086-235-6847

Email

watanabe1224@okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shogo WATANABE

Organization

Graduate school of health sciences, Okayama university

Division name

Department of Medical Technology

Zip code


Address

2-5-1 sikata-cho kita-ku okayama city, Okayama, Japan

TEL

086-235-6847

Homepage URL


Email

watanabe1224@okayama-u.ac.jp


Sponsor or person

Institute

Nagoya university

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Young Scientists(B)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 11 Month 27 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

2013 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 27 Day

Last modified on

2015 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023035


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name