UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 03 Month 21 Day

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