UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049755 |
|---|---|
| Receipt number | R000056670 |
| Scientific Title | Exploring factors associated with frailty and sarcopenia in patients with chronic obstructive pulmonary disease: multicenter prospective observational study in Japan |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/02/04 11:45:06 |
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Basic information
Public title
Exploring factors associated with frailty and sarcopenia in patients with chronic obstructive pulmonary disease: multicenter prospective observational study in Japan
Acronym
Frailty and Sarcopenia in COPD
Scientific Title
Exploring factors associated with frailty and sarcopenia in patients with chronic obstructive pulmonary disease: multicenter prospective observational study in Japan
Scientific Title:Acronym
Frailty and Sarcopenia in Japanese patients with COPD
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore pulmonary and extrapulmonary factors associated with development and progression of frailty and sarcopenia in patients with COPD
Basic objectives2
Others
Basic objectives -Others
Prospective observational study to identify risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations of baseline pulmonary and extrapulmonary pathophysiological changes in CT with 3-year longitudinal changes in frailty and sarcopenia
Key secondary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with COPD at aged between 50 and 85 and control smokers without COPD at aged between 50 and 85
Key exclusion criteria
Inability to fill in self-reported questionnaires. Unstable conditions.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | NAOYA |
| Middle name | |
| Last name | TANABE |
Organization
Kyoto University
Division name
Department of Respiratory Medicine / Rehabilitation Unit
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
0757513830
ntana@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Tanabe |
Organization
Kyoto University
Division name
Department of Respiratory Medicine / Rehabilitation Unit
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
0757513830
Homepage URL
ntana@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Committees of Kyoto University Hospital
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
Tel
0757514680
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院、北野病院、滋賀医科大学医学部附属病院、神戸市立医療センター中央市民病院、洛和会音羽病院、神鋼記念病院、寺田内科呼吸器内科、大津赤十字病院、河端病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with stable COPD and control subjects are enrolled and undergo symptomatic assessment, pulmonary function test, chest CT, and questionnaires for frailty and sarcopenia. Then, they are follow-up annually over 3 years. Six-minute walking test, muscle strength measurement, quantification of body composition, and physical activity are also evaluated annually when consent is obtained.
Management information
Registered date
| 2022 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056670
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
