UMIN-CTR Clinical Trial

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）

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