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

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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 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

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

Value
https://center6.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