UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021363 |
|---|---|
| Receipt number | R000024637 |
| Scientific Title | Observational study on physical activity and frequency of acute exacerbation in COPD |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2024/03/13 11:10:15 |
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Basic information
Public title
Observational study on physical activity and frequency of acute exacerbation in COPD
Acronym
Physical activity and exacerbation frequency in COPD
Scientific Title
Observational study on physical activity and frequency of acute exacerbation in COPD
Scientific Title:Acronym
Physical activity and exacerbation frequency in COPD
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe relation between physical activity and frequency of acute exacerbation in COPD
Basic objectives2
Others
Basic objectives -Others
to explore risk factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relation between physical activity and frequency of acute exacerbation during 12 months after enrollment in stable COPD
Key secondary outcomes
Relation between physical activity and frequency of acute exacerbation during 24 months before enrollment in stable COPD
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
diagnosis of COPD
Key exclusion criteria
1) unable to respond questionnaire
2) unable to wear a 3-axis accelerometer
3) acute exacerbation within 2 month before enrollment
4) unable to walk
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yoshida |
Organization
National Hospital Organization Fukuoka Hospital
Division name
Division of Respiratory Medicine
Zip code
811-1394
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL
092-565-5534
yoshida.makoto.sv@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Yoshida |
Organization
National Hospital Organization Fukuoka Hospital
Division name
Division of Respiratory Medicine
Zip code
811-1394
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL
092-565-5534
Homepage URL
yoshida.makoto.sv@mail.hosp.go.jp
Sponsor or person
Institute
Department of pulmonary medicine, graduate school of medical & dental sciences, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health Labour and Welfare, Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Fukuoka Hospital
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
Tel
092-565-5534
yoshida.makoto.sv@mail.hosp.go.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
| 2016 | Year | 03 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: case-control study
Subject recruitment: COPD outpatients regularly visiting National Hospital Organization Fukuoka Hosptal
Recruiting period: from 01 NOV 2014 to 31 OCT 2016
Primary endpoint: effects of physical activity, lung function and comorbidities on frequency of acute exacerbation
Management information
Registered date
| 2016 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024637
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
