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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043290
Receipt No. R000049302
Scientific Title Research on effect of preceding inspiration method and cough timing on coughing power
Date of disclosure of the study information 2021/02/15
Last modified on 2021/02/09

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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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