UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029530 |
|---|---|
| Receipt number | 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 | 2021/03/21 11:51:19 |
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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
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
hiromichi.takeda0608@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033744
