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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027513
Receipt No. 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

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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
Email 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
Email lirfranjitte@gmail.com

Sponsor
Institute Okayama University Hospital
General rehabilitation department
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031538

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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