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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032112
Receipt No. R000036633
Scientific Title A prospective cohort study of outpatients with COPD on physical activity
Date of disclosure of the study information 2018/04/06
Last modified on 2018/05/02

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Basic information
Public title A prospective cohort study of outpatients with COPD on physical activity
Acronym COPD and physical activity
Scientific Title A prospective cohort study of outpatients with COPD on physical activity
Scientific Title:Acronym COPD and physical activity
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe the physical activity in community-dwelling patients with COPD.
Basic objectives2 Others
Basic objectives -Others To evaluate the impact of physical activity level on clinical outcomes of COPD in a Japanese outpatient COPD cohort
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical activity level
Key secondary outcomes The impact of physical activity level on clinical outcomes of 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 Patients with stable COPD, who are aged 40 years and older, and have a smoking history of at least 10 pack-years.
Key exclusion criteria exacerbation of COPD in the 4 weeks preceding data collection.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Kobayashi
Organization Japanese Red Cross Ishinomaki Hospital
Division name Department of Respiratory Medicine
Zip code
Address 71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL 0225-21-7220
Email skoba-thk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichi Kobayashi
Organization Japanese Red Cross Ishinomaki Hospital
Division name Department of Respiratory Medicine
Zip code
Address 71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL 0225-21-7220
Homepage URL
Email skoba-thk@umin.ac.jp

Sponsor
Institute Japanese Red Cross Ishinomaki Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Ishinomaki COPD Network (ICON)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 石巻赤十字病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 06 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
2018 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective cohort study based on Ishinomaki COPD Network (ICON) registry. This study is part of an on-going COPD cohort study registered with the UMIN-CTR (identifiler: UMIN000017376).

Management information
Registered date
2018 Year 04 Month 05 Day
Last modified on
2018 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036633

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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