UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042106 |
|---|---|
| Receipt number | R000048052 |
| Scientific Title | The impact of COVID19 pandemic-related activity restriction on the outcomes of chronic obstructive lung disease |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2023/04/17 09:34:04 |
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Basic information
Public title
The impact of COVID19 pandemic-related activity restriction on the outcomes of chronic obstructive lung disease
Acronym
ICARD study
Scientific Title
The impact of COVID19 pandemic-related activity restriction on the outcomes of chronic obstructive lung disease
Scientific Title:Acronym
ICARD study
Region
| Japan |
Condition
Condition
chronic obstructive lung disease(COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of COVID19 pandemic-related activity restriction on the outcomes of chronic obstructive lung disease
Basic objectives2
Others
Basic objectives -Others
This study is aimed to investigate the actual situation of COVID19 pandemic-related activity restriction in COPD patients and to evaluate the impact of activity restriction on COPD-related outcomes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity evaluated by IPAQ during COVID19 pandemic period
Key secondary outcomes
1. Sedentary time during COVID19 pandemic period
2. Prevalence of COVID19 in this study population
3. The numbers of COPD-related acute exacerbation (AE) after COVID19 pandemic
4. The chance of spirometric valuables after COVID19 pandemic
5. Estimation of anxiety and depression evaluated by HADS on enroll
6. Identification of factors related to COPD-AE
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
COPD: Patients who meet three criteria:
(1-1) cases diagnosed as COPD on registration
(2) above 40 years-old
(3) written informed consent
Non-COPD: Patients who meet three criteria:
(1-2) never-smokers with FEV1/FVC >70%
(2) above 40 years-old
(3) written informed consent
Key exclusion criteria
(1) cases who disagree with evaluation of COPD status
(2) cases who investigators could not evaluate the incidence of COPD-related AE by medical record
(3) cases carrying malignant tumors
(4) cases with asthma
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Naozumi |
| Middle name | |
| Last name | Hashimoto |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
4668550
Address
65 Tsurumai, Showa-Ku, Nagoya, Aichi, Japan
TEL
0527442167
hashinao@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ando |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
4668550
Address
65 Tsurumai, Showa-Ku, Nagoya, Aichi, Japan
TEL
0527442167
Homepage URL
ICARD.kokyuki@outlook.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine,
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-741-2111
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 15 | 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
122
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
| 2020 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observationa Study ongoing
Management information
Registered date
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048052
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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