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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042261
Receipt No. R000048244
Scientific Title The relationship between tongue pressure and body composition in patients with chronic obstructive pulmonary disease.
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/27

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Basic information
Public title The relationship between tongue pressure and body composition in patients with chronic obstructive pulmonary disease.
Acronym The relationship between tongue pressure and body composition in patients with chronic obstructive pulmonary disease.
Scientific Title The relationship between tongue pressure and body composition in patients with chronic obstructive pulmonary disease.
Scientific Title:Acronym The relationship between tongue pressure and body composition in patients with chronic obstructive pulmonary disease.
Region
Japan

Condition
Condition chronic obstructive pulmonary disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the characteristic of the tongue pressure in COPD patients compared with subjects without pulmonary disease.
Basic objectives2 Others
Basic objectives -Others To investigate the correlation between tongue pressure and body composition, strength, physical function in COPD patients.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes tongue pressure
Key secondary outcomes Handgrip strength
gait speed
Body mass index(BMI)
appendicular skeletal muscle mass(ASM)
skeletal muscle mass index(SMI)
eating assessment test-10(eat-10)

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 subjects (> 65 years old) with stable COPD who visits the Department of Respiratory Medicine and Allergology at Kindai University Hospital
Key exclusion criteria Subjects with metallic implants and a history of stroke or neuromuscular disease. Subjects who did not have their front teeth will exclude, because they will not be able to bite down on the equipment use to measure tongue pressure.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Ryuji
Middle name
Last name Sugiya
Organization Kindai university hospital
Division name department of rehabilitation medicine
Zip code 5898511
Address 377-2 Onohigashi, Osakasayama-city, Osaka-prefecture, Japan
TEL 072-366-0221
Email ryuji.sugiya@med.kindai.ac.jp

Public contact
Name of contact person
1st name Ryuji
Middle name
Last name Sugiya
Organization Kindai university hospital
Division name department of rehabilitation medicine
Zip code 5898511
Address 377-2 Onohigashi, Osakasayama-city, Osaka-prefecture, Japan
TEL 072-366-0221
Homepage URL
Email ryuji.sugiya@med.kindai.ac.jp

Sponsor
Institute Kindai university hospital
Institute
Department

Funding Source
Organization Kindai university hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization kindai university hospital
Address 377-2 Onohigashi, Osakasayama-city, Osaka-prefecture, Japan
Tel 072-366-0221
Email ryuji.sugiya@med.kindai.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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 01 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 51
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
2019 Year 11 Month 01 Day
Date of IRB
2019 Year 10 Month 17 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A single-centre, observational, and cross-sectional study.

Management information
Registered date
2020 Year 10 Month 27 Day
Last modified on
2020 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048244

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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