UMIN-CTR Clinical Trial

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

neuromuscular disease,
bed rest

Classification by specialty

Pneumology

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Kio university

Institute

Department

Personal name

Organization

Kio university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

八尾はぁとふる病院(大阪府)
畿央大学(奈良県)

Date of disclosure of the study information

2013

Year

05

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2013

Year

05

Month

25

Day

Last modified on

2013

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012635