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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019947
Receipt No. 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

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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
Last 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
1st 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
Institute Nagoya university
Institute
Department

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
URL(English) https://upload.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


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