UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042106
Receipt No. 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 2020/10/14

* 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 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
Email 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
Email ICARD.kokyuki@outlook.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email 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
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 Open public 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

Management information
Registered date
2020 Year 10 Month 14 Day
Last modified on
2020 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.