UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of respiratory physiotherapy on respiratory mechanics
Title of the study (Brief title)	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
Name of lead principal investigator	Yosuke Wada
Organization	Hyogo college of medicine sasayama medical center
Division name	department of rehabilitation
Address	5,kurooka,sasayama,hyogo,japan
TEL	079-552-1181
Email	shige-pt@hyo-med.ac.jp

Public contact
Name of contact person	Shigefumi murakami
Organization	Hyogo college of medicine sasayama medical center
Division name	department of rehabilitation
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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