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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010800
Receipt No. R000012635
Scientific Title The influence which the body pressure balancing function in an air mattress has on Cough Peak Flow and Respiratory Muscle Strength.
Date of disclosure of the study information 2013/05/25
Last modified on 2013/11/25

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Basic information
Public title The influence which the body pressure balancing function in an air mattress has on Cough Peak Flow and Respiratory Muscle Strength.
Acronym The influence which the body pressure balancing function in an air mattress has on Cough Peak Flow and Respiratory Muscle Strength.
Scientific Title The influence which the body pressure balancing function in an air mattress has on Cough Peak Flow and Respiratory Muscle Strength.
Scientific Title:Acronym The influence which the body pressure balancing function in an air mattress has on Cough Peak Flow and Respiratory Muscle Strength.
Region
Japan

Condition
Condition neuromuscular disease,
bed rest
Classification by specialty
Pneumology Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The patient who cannot do a postural change in self has forced at least bed rest. Efficient cough on a mattress is needed also for prevention of respiratory-organs complications, such as a respiratory failure and pneumonia. However, about the relation between the mattress which is an environment factor, Cough, and respiratory muscle strength, there is almost no report. Then, the body pressure balancing function of the air mattress with which the postural change in self is recommended to a difficult patient this time aims at investigating whether it is related to cough and respiratory muscle strength.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes respiratory muscle strength:(maximal expiratory pressure,MEP;maximal inspiratory pressure,MIP)
the body pressure balancing function:contact area
Key secondary outcomes vital capacity,VC
forced vital capacity,FVC(FEV1.0,FEV1.0%,PEF)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Three kinds of a standard mattress and an air mattress Hard or Soft are set up at random.It blocks all the 6 kinds at two kinds of 3 blocks.With man and woman blocking is stratificationized in the registered order and is assigned to it.
It becomes semirandom by each block.standard mattress,air soft,air hard.standard mattress,air hard,air soft.
Interventions/Control_2 air hard,air soft,standard mattress.air hard,standard mattress,air soft.
Interventions/Control_3 air Soft,standard mattress,air Hard.
air Soft,air Hard,standard mattress.
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
45 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adult
Key exclusion criteria Existence of a respiratory ailment, a smoking history, a deformity of the spine
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Morita
Organization Kio university
Division name Health science graduate course
Zip code
Address Nara Kitakatsuragi Koryo county town Umaminaka 4-2-2
TEL 0745-54-1601
Email shinichi9029@helen.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Morita
Organization Yao Heartful hospital
Division name Rehabilitation division
Zip code
Address Osaka Yao Misono-cho 2-18-1
TEL 072-999-0725
Homepage URL
Email shinichi9029@helen.ocn.ne.jp

Sponsor
Institute Kio university
Institute
Department

Funding Source
Organization Kio university
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
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 八尾はぁとふる病院(大阪府)
畿央大学(奈良県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 25 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
2013 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Turn of a mattress is made random.
Using ANOVA (analysis of variance), in order to investigate the significant difference of each group, a multiple comparison is performed in comparison of the body pressure balancing function(soft-hard and standard) of a mattress by the Tukey method.
Moreover,Respiratory Muscle Strength (MEP-MIP) and PEF,CPF also investigate the significant difference of each group, and conduct correlation analysis of Pearson for relationship similarly, respectively.

Management information
Registered date
2013 Year 05 Month 25 Day
Last modified on
2013 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012635

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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