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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031751
Receipt No. R000036253
Scientific Title Relationship between kyphosis posture of elderly people and respiratory function,voluntary cough intensity
Date of disclosure of the study information 2018/03/15
Last modified on 2019/04/16

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Basic information
Public title Relationship between kyphosis posture of elderly people and respiratory function,voluntary cough intensity
Acronym Relationship between kyphosis posture of elderly people and respiratory function,voluntary cough intensity
Scientific Title Relationship between kyphosis posture of elderly people and respiratory function,voluntary cough intensity
Scientific Title:Acronym Relationship between kyphosis posture of elderly people and respiratory function,voluntary cough intensity
Region
Japan

Condition
Condition kyphosis elderly people
Classification by specialty
Pneumology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between kyphosis posture and respiratory function,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 3m gait speed, grip strength, 30-sec chair stand test, knee extensor strength, long seat body bending forward, functional reach test, sit and reach test, timed up and go test

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Elderly people over 65 years old
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
Zip code 635-2832
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
Zip code 635-2832
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 デイサービス リハステージ日本橋(大阪府)、デイサービス リハステージ中津(大阪府)、デイサービス リハステージ上新庄(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 15 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 20
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 No longer recruiting
Date of protocol fixation
2018 Year 03 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 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 03 Month 15 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036253

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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