UMIN-CTR Clinical Trial

Basic information
Public title	Effect of preceding inspiration method and cough timing on coughing power
Acronym	Effect of preceding inspiration method and cough timing on coughing power
Scientific Title	Research on effect of preceding inspiration method and cough timing on coughing power
Scientific Title:Acronym	Research on effect of preceding inspiration method and cough timing on coughing power
Region	Japan

Condition
Condition	Obstructive ventilatory disturbance, Restrictive ventilatory disturbance
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.To examine the differences in cough force depending on the inspiration method and cough timing, and to establish an appropriate measurement method for coughing power. 2.To examine the differences in measurement results between normal subjects and patients with respiratory diseases, and to contribute not only to measurement but also to coughing practice and patient guidance in respiratory physiotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Peak cough flow
Key secondary outcomes	Forced Vital Capacity Percent predicted Forced Vital Capacity Forced Expiratory Volume in 1 second Percent predicted Forced Expiratory Volume in one second Forced Expiratory Volume in 1 second as percent of FVC Percent predicted Forced Expiratory Volume in 1 second as percent of FVC Maximal Voluntary Ventilation Percent predicted Maximal Voluntary Ventilation Peak Expiratory Flow Percent predicted Peak Expiratory Flow V75-25 Percent predicted V75-25

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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Coughing power test For this measurement, the spirometer will be attached to a mask for expiratory gas analysis. The coughing power is measured under the following four conditions. Condition 1: Cough without an end-inspiratory pause after fast inspiration Condition 2: Cough with an end-inspiratory pause after fast inspiration Condition 3: Cough without an end-inspiratory pause after slow inspiration Condition 4: Cough with an end-inspiratory pause after slow inspiration For an end-inspiratory pause, the subject watch a timer and coughing after 4 to 6 seconds of respiratory arrest. The measurement position should be sitting, or wheelchair or chair sitting if the sitting position is unstable. The measurement consists of two or three practice sessions, followed by three measurements, and the one with the maximum PCF value is adopted.
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	Healthy subject 1) Healthy subjects over 20 years old 2) Subjects who can give consent in writing for participation in this study 3) Non-smokers or light smokers with a Brinkman index of less than 100 Respiratory disease patients 1) Patients aged over 20 years old 2)Patients who can give consent in writing for participation in this study 3) Patients who are outpatients at Gunma University Hospital 4) Patient with restrictive ventilation disorder or obstructive ventilation disorder
Key exclusion criteria	1)Patients with unexplained blood sputum 2) Patients diagnosed with angina pectoris 3) Patients suffering from unstable cardiovascular disease 4) Patients diagnosed with myocardial infarction or pulmonary embolism 5) Patients with aortic aneurysm 6) Patients immediately after eye surgery (cataract or glaucoma) 7) Patients who have undergone thoracic or abdominal surgery 8) Patients who are unable to give explanation and consent due to cognitive function or psychiatric symptoms
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Hisada
Organization	Gunma University
Division name	Graduate School of Health Sciences / Department of Respiratory Medicine and Allergy
Zip code	371-8514
Address	3-39-22, Showa-machi, Maebashi, Gunma
TEL	027-220-8944
Email	hisadat@gunma-u.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Hisada
Organization	Gunma University
Division name	Graduate School of Health Sciences / Department of Respiratory Medicine and Allergy
Zip code	371-8511
Address	3-39-22, Showa-machi, Maebashi, Gunma
TEL	027-220-8944
Homepage URL
Email	hisadat@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Gunma 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	Gunma University Hospital Clinical Research Review Board
Address	3-39-15, Showa-machi, Maebashi, Gunma
Tel	027-220-8740
Email	gunmaciru-office@umin.ac.jp

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	群馬大学医学部附属病院（群馬県）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 15 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	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 01 Month 28 Day
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 09 Day
Last modified on	2021 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049302

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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