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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027965
Receipt No. R000031945
Scientific Title Effects of respiratory physiotherapy on respiratory mechanics
Date of disclosure of the study information 2017/08/01
Last modified on 2017/06/27

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Basic information
Public title Effects of respiratory physiotherapy on respiratory mechanics
Acronym Effects of respiratory physiotherapy on respiratory mechanics
Scientific Title Effects of respiratory physiotherapy on respiratory mechanics
Scientific Title:Acronym Effects of respiratory physiotherapy on respiratory mechanics
Region
Japan

Condition
Condition normal subject
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of respiratory physiotherapy on respiratory mechanics in normal subjects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes preural pressure and abdominal pressure
lung volume and flow rates
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 respiratory physiotherapy
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 1.Normal subjects without cardiopulmonary disorder
2.Written informed consent is provided
Key exclusion criteria 1.Participants with cardiopulmonary disorder
2.non-approval for study participation
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yosuke Wada
Organization Hyogo college of medicine sasayama medical center
Division name department of rehabilitation
Zip code
Address 5,kurooka,sasayama,hyogo,japan
TEL 079-552-1181
Email shige-pt@hyo-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shigefumi murakami
Organization Hyogo college of medicine sasayama medical center
Division name department of rehabilitation
Zip code
Address 5,kurooka,sasayama,hyogo,japan
TEL 079-552-1181
Homepage URL
Email yu-wada@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 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
2017 Year 06 Month 28 Day
Last modified on
2017 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031945

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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