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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029530
Receipt No. R000033744
Scientific Title Influence of simulated kiphosis posture on pulmonary function and voluntary cough intensity
Date of disclosure of the study information 2017/10/15
Last modified on 2020/08/05

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Basic information
Public title Influence of simulated kiphosis posture on pulmonary function and voluntary cough intensity
Acronym Influence of simulated kiphosis posture on pulmonary function and voluntary cough intensity
Scientific Title Influence of simulated kiphosis posture on pulmonary function and voluntary cough intensity
Scientific Title:Acronym Influence of simulated kiphosis posture on pulmonary function and voluntary cough intensity
Region
Japan

Condition
Condition Healthy Young man
Classification by specialty
Pneumology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the influence of kiphosis posture on pulmonary function and voluntary cough intensity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes vital capacity, forced vital capacity, cough peak flow, thorax mobility, maximum expiratory pressure, maximum inspiratory pressure, maximum phonation time, thoracic spinal curvature, lumbar spinal curvature,respiratory resistance,respiratory muscle activity
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Healthy young people between the ages of 18 and 40
Key exclusion criteria Pulmonery diseases, those with central nervous system disease

Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiromichi
Middle name
Last name Takeda
Organization Kio University
Division name Division of Health Science, Graduate School of Health Science
Zip code 635-0832
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL 0745-54-1601
Email hiromichi.takeda0608@gmail.com

Public contact
Name of contact person
1st name Hiromichi
Middle name
Last name Takeda
Organization Kio University
Division name Division of Health Science, Graduate School of Health Science
Zip code 635-0832
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL 0745-54-1601
Homepage URL
Email hiromichi.takeda0608@gmail.com

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio University
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 Kio University
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
Tel 0745-54-1602
Email soumu@kio.ac.jp

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 畿央大学(奈良県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 15 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_11651/_pdf/-char/ja
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_11651/_pdf/-char/ja
Number of participants that the trial has enrolled 16
Results
In CPF, VC, ERV, and MPT, a significant decrease was observed in the moderately kyposis and the severely kyphosis (p<0.05). In the axilla and xiphoid region of the difference in chest expansion, significant reductions were observed in mild, moderate, and severe kyphosis (p<0.05). PEmax was significantly lower in the severe kyphosis than in the mild kyphosis (p<0.05). 
Results date posted
2020 Year 08 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
age(y)	    25.9
height(cm)	173.2	
weight(kg)	67.9
BMI    	22.6
Participant flow
The subjects were healthy young men.
Subjects with spinal disease, respiratory disease, or chest deformity were excluded.
Adverse events
None
Outcome measures
CPF
VC
ERV
FEV1/FVC
PEmax
PImax
chest expansion
MPT
R5
Fres
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 10 Month 15 Day
Date of IRB
2018 Year 04 Month 17 Day
Anticipated trial start date
2018 Year 04 Month 18 Day
Last follow-up date
2019 Year 06 Month 01 Day
Date of closure to data entry
2019 Year 08 Month 01 Day
Date trial data considered complete
2019 Year 09 Month 01 Day
Date analysis concluded
2019 Year 10 Month 01 Day

Other
Other related information Consider whether there is a correlation between the vertebral angle of kyphosis, pulmonary function, and voluntary cough intensity

Management information
Registered date
2017 Year 10 Month 12 Day
Last modified on
2020 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033744

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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