UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050781 |
|---|---|
| Receipt number | R000057615 |
| Scientific Title | Comparison of Huffing and peak flow expiratory flow values in healthy adults. |
| Date of disclosure of the study information | 2023/06/19 |
| Last modified on | 2024/04/07 13:40:47 |
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Basic information
Public title
Comparison of Huffing and peak flow expiratory flow values in healthy adults.
Acronym
Comparison of Huffing and peak flow expiratory flow values in healthy adults.
Scientific Title
Comparison of Huffing and peak flow expiratory flow values in healthy adults.
Scientific Title:Acronym
Comparison of Huffing and peak flow expiratory flow values in healthy adults.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The exhalation in huffing and peak flow tests is both forced exhalation that opens the glottis. Therefore, the huffing and peak flow meter exhalation values are verified to be close or correlated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Huffing and peak flow expiratory flow values in healthy adults
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Over a period of one or two days, subjects are given six alternating huffing and peak flow tests.After that, two additional peak flow tests are performed.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults with no history of bronchospasm
Persons who have obtained written consent to participate in the study
18 years of age or older at the time of obtaining consent
Key exclusion criteria
Those with a history of bronchospasm
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | ayako |
| Middle name | |
| Last name | shimizu |
Organization
National Center for Global Health and Medicine
Division name
Department of Rehabilitation
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, JAPAN
TEL
03-3202-7181
ayshimizu@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | ayako |
| Middle name | |
| Last name | shimizu |
Organization
National Center for Global Health and Medicine
Division name
Department of Rehabilitation
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, JAPAN
TEL
03-3202-7181
Homepage URL
ayshimizu@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
NO
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
Clinical Research Clerkship National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, JAPAN
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 19 | 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
30
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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057615
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
