UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of breathing exercises pattern on ventilator efficiency
Title of the study (Brief title)	Effects of breathing exercises pattern on ventilator efficiency
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of self-selected, natural deep breathing versus instructed diaphragmatic deep breathing in healthy adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of ventilatory efficiency between quiet and deep breathing phases
Key secondary outcomes	1.Comparison of heart rate between quiet and deep breathing phases 2.Comparison of autonomic nervous system activity between quiet and deep breathing phases

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	1.Natural, self-selected deep breathing 2.Instructed diaphragmatic deep breathing
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults who gave informed consent
Key exclusion criteria	History of severe cardiopulmonary disease
Target sample size	20

Research contact person
Name of lead principal investigator	Masami Yokogawa
Organization	Kanazawa University
Division name	Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences
Address	11-80, Kodatsuno 5, Kanazawa
TEL	076-265-2618
Email	yokogawa@mhs.mp.kanazawa-u.ac.jp

Public contact
Name of contact person	Masami Yokogawa
Organization	Kanazawa University
Division name	Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences
Address	11-80, Kodatsuno 5, Kanazawa
TEL	076-265-2618
Homepage URL
Email	yokogawa@mhs.mp.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	None
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 06 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 10 Day
Anticipated trial start date	2014 Year 11 Month 21 Day
Last follow-up date	2014 Year 12 Month 01 Day
Date of closure to data entry	2014 Year 12 Month 11 Day
Date trial data considered complete	2014 Year 12 Month 11 Day
Date analysis concluded	2015 Year 11 Month 09 Day

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

Management information
Registered date	2017 Year 06 Month 24 Day
Last modified on	2017 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031972