UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031751 |
|---|---|
| Receipt number | 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 | 2021/03/21 11:50:12 |
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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
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
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
デイサービス リハステージ日本橋（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
https://kinki60.pt-osk.or.jp/img/0210PT-K60_abst.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://kinki60.pt-osk.or.jp/img/0210PT-K60_abst.pdf
Number of participants that the trial has enrolled
38
Results
Comparison of non-kyphotic and kyphotic groups
A comparison of the respiratory function between the non-kyphotic and kyphotic groups. CPF (d = 7), VC (d = 0.8), PEmax (d = 1.2), PImax (d = 1.3), and chest expansion at the xiphoid process (d = 0.8) were significantly lower in the kyphotic group than in the non-kyphotic group.
Results date posted
| 2021 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age
Total 81.1(7.1), Non-kyphosis 81.1(7.9), kyphosis 81.1(6.5)
Gender (female/male)
Total 24/14, Non-kyphosis 10/7, Kyphosis 14/7
Kyphosis index
Total 16.0(4.4), Non-kyphosis 12.0(1.6), Kyphosis 19.2(3.1)
Participant flow
The participants of this study consisted of community-dwelling elderly (average age 81.1(7.1) years) from an elderly day care center. All participants were assessed for their kyphosis index. The 38 elderly individuals were divided into non-kyphotic and kyphotic groups based on the kyphosis index. The non-kyphotic group consisted of 17 elderly individuals with a kyphosis index of less than 15.1, while the kyphotic group consisted of 21 elderly individuals with a kyphosis index of 15.1 or higher. Patients with a diagnosed respiratory disease were excluded.
Adverse events
None
Outcome measures
Cough strength, Respiratory and physical function
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 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=R000036253
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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