UMIN-CTR Clinical Trial

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