UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022133 |
|---|---|
| Receipt number | R000025486 |
| Scientific Title | effects of tongue elevation and pushing has on the optional cough force |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2017/05/27 11:00:03 |
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Basic information
Public title
effects of tongue elevation and pushing has on the optional cough force
Acronym
study of cough
Scientific Title
effects of tongue elevation and pushing has on the optional cough force
Scientific Title:Acronym
study of cough
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of the method for increasing the optional cough force
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
peak cough flow
Key secondary outcomes
age,gender,height,weight,BMI
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The maximum expiratory volume at the time of optional cough is measured three times. The measure to use those connecting the face mask to assessment peak flow meter.
Interventions/Control_2
Optionally cough when is conscious of the breath hold on, to measure the maximum expiratory volume in the same way as in intervention 1.
Interventions/Control_3
Optionally cough when to consciousness on the breath-holding and tongue raise, to measure the peak expiratory flow in the same way as in intervention 1.
Interventions/Control_4
Optionally cough when is conscious of the breath hold asked by pushing the front of the wall, to measure the peak expiratory flow in the same way as in intervention 1.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
history without a healthy adult of respiratory disease
it can be obtained the consent of the research participation by free will in writing from the person
age at the time of obtaining informed consent or more and less than 20 years old 50 years of age
gender: no preference
affiliation: Okayama University who belong to the hospital and Medical Technology Department, Rehabilitation Department
who is physical, mental and social disadvantage by participation in this study do not occur
those who are understanding of the clinical significance and its importance with the present study
Key exclusion criteria
women that may be in or pregnancy
a person who has a throat pain
with cold symptoms who
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tomohiro ikeda |
Organization
Okayama University Hospital
Division name
General Department of Rehabilitation
Zip code
Address
Okayama, Okayama Prefecture, Kita-ku, Shikata-cho, 2-5-1
TEL
086-235-7752
lirfranjitte@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | tomohiro ikeda |
Organization
Okayama University Hospital
Division name
General Department of Rehabilitation
Zip code
Address
Okayama, Okayama Prefecture, Kita-ku, Shikata-cho, 2-5-1
TEL
086-235-7752
Homepage URL
lirfranjitte@yahoo.co.jp
Sponsor or person
Institute
Okyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025486
