UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027513 |
|---|---|
| Receipt number | R000031538 |
| Scientific Title | Study on the influence of hardness of air mattress on optional coughing power in sitting posture |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/12/23 16:19:38 |
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Basic information
Public title
Study on the influence of hardness of air mattress on optional coughing power in sitting posture
Acronym
Hardness of air mattress and breathing function
Scientific Title
Study on the influence of hardness of air mattress on optional coughing power in sitting posture
Scientific Title:Acronym
Hardness of air mattress and breathing function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While air mattresses disperse body pressure and reduce local pressure, it has been reported that in the supine position the spinal curvature is enhanced, lowering coughing power and respiratory function. Even on a sitting posture (60 degrees of gathering up + 20 degrees of knee raising), spinal curvature arises on air mattresses and it is expected to reduce the optional coughing power. However, as far as the researchers were concerned, no report was found, so we reached the implementation of this research
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
peak cough flow
Key secondary outcomes
Age, gender, height, weight, BMI, grip strength, lung capacity, effortive lung capacity, 1 second rate, maximum inspiratory pressure, maximum expiratory pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Take a gatch up sitting posture on the air mattress (pressure is set optimally)
Interventions/Control_2
Take a gatch up sitting posture on the air mattress (pressure is set optimally)
Interventions/Control_3
Take a gatch up sitting posture on the air mattress (pressure set to minimum)
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adult with no history of respiratory disease or spinal column disease
It is possible to acquire the consent of research participation by voluntary intention from the principal in writing
Persons who do not suffer physical, mental and social disadvantages due to participation in this research
Person who understands the clinical significance of this research and its importance
Key exclusion criteria
Women who are pregnant or have a possibility of pregnancy
Those with pharyngeal pain
Persons with common cold symptoms
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 rehabilitation department
Zip code
Address
700-8558,Okayamashi,kitaku,ksikatacho,2-5-1
TEL
086-235-7752
lirfranjitte@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ikeda |
Organization
Okayama University Hospital
Division name
General rehabilitation department
Zip code
Address
700-8558,Okyamashi,kitaku,sikatacho,2-5-1
TEL
086-235-7752
Homepage URL
lirfranjitte@gmail.com
Sponsor or person
Institute
Okayama University Hospital
General rehabilitation department
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
General rehabilitation department
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 08 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031538
