UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042261 |
|---|---|
| Receipt number | 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 18:43:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ryuji.sugiya@med.kindai.ac.jp
Sponsor or person
Institute
Kindai university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048244
