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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022659
Receipt No. R000026092
Scientific Title The influence of inspiratory muscle loading on cardiopulmonary response
Date of disclosure of the study information 2016/06/08
Last modified on 2016/06/08

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Basic information
Public title The influence of inspiratory muscle loading on cardiopulmonary response
Acronym The influence of inspiratory muscle loading on cardiopulmonary response
Scientific Title The influence of inspiratory muscle loading on cardiopulmonary response
Scientific Title:Acronym The influence of inspiratory muscle loading on cardiopulmonary response
Region
Japan

Condition
Condition healthy person
chronic heart failure
Classification by specialty
Cardiology Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate cardiopulmonary response during inspiratory muscle loading
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes oxygen consumption,
carbon dioxide output,
respiration quotient, tidal volume, systolic bloodpressure, heart rate, stroke volume, cardiac output,
autonomic nerve activity
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A parson who can evaluate inspiratory muscle strength
Key exclusion criteria A parson with a history of pulmonary disease

Smoker

A parson who 60% of the maximum inspiratory muscle strength is less than or equal to 40cmH2O
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Sato
Organization Kio University
Division name Division of Health Science, Graduate School of Health Science
Zip code
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL 0745-54-1601
Email sugar430sato@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Sato
Organization Kio University
Division name Division of Health Science, Graduate School of Health Science
Zip code
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL 0745-54-1601
Homepage URL
Email sugar430sato@yahoo.co.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio 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
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
2016 Year 06 Month 08 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
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruitment method
Convene all those who meet the selection criteria

Recruitment period
June to August 2016

Management information
Registered date
2016 Year 06 Month 08 Day
Last modified on
2016 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026092

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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