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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032962
Receipt No. R000037589
Scientific Title A non-interventional, cross-sectional study for evaluating factors relating to daily step counts and physical activity in Japanese patients with COPD
Date of disclosure of the study information 2018/06/20
Last modified on 2018/06/13

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Basic information
Public title A non-interventional, cross-sectional study for evaluating factors relating to daily step counts and physical activity in Japanese patients with COPD
Acronym STEP COPD
Scientific Title A non-interventional, cross-sectional study for evaluating factors relating to daily step counts and physical activity in Japanese patients with COPD
Scientific Title:Acronym STEP COPD
Region
Japan

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

Objectives
Narrative objectives1 Aim of this study is to reveal the Physical Activity Level (PAL) of patients with COPD in real world setting. And the factors relating with physical activity will be identified in this study. We also identify the characteristics of patients whose PAL be strongly correlated with lung function and/or symptoms.
Basic objectives2 Others
Basic objectives -Others Evaluation of the number of daily steps in subgroups of COPD patients grouped according to patient characteristics including lung functions, mMRC, and CAT scores.
Elucidation of impacts of factors associating PAL in COPD patients.
Elucidating exploratorily the characteristics of the patients who are distributed differently in each factor and analyzing patients PAL further with their background.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Daily step of patients with COPD
2)Average time of each activity level
3)Correlation between physical activity level and other factor
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Patients from whom written consent to participate in this study has been obtained.
-Females and males aged 40 years or older at the time of registration, who were diagnosed with COPD by physicians (patients with forced expiratory volume in one second/ forced vital capacity [FEV1/FVC] ratio <70% post-bronchodilator inhalation within the past year or on registration).
-Patients who have lung function tests performed within the past three months as well as within the past two years on the registration.
-Patients who have chest CT performed within the past year or on registration.
-Outpatients deemed capable of answering the questionnaires within 8 weeks following registration and measuring their daily step counts using pedometers for 14 consecutive days.
Key exclusion criteria -Patients who participated in other interventional studies including clinical trials within the last 3 months.
-Patients who are suspected to have a poor capability to follow study instructions (e.g. due to a history of alcoholism or drug abuse, planned to admission during the study, or dementia) or patients judged by physicians as whom would have obviously biased outcomes due to their other diseases (e.g. Osteoarthritis, mental illness, dementias, tumors, etc...).
-Patients with exacerbations within the last 8 weeks.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigetaka Kouda
Organization AstraZeneca.KK.
Division name Medical
Zip code
Address 3-1, Ofuna-cho, Kita-ku, Osaka
TEL 06-7711-3714
Email Tatsunori.Jinnai@astrazeneca.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Jinnai
Organization AstraZeneca.KK.
Division name Medical
Zip code
Address 3-1, Ofuna-cho, Kita-ku, Osaka
TEL 06-7711-3714
Homepage URL
Email Tatsunori.Jinnai@astrazeneca.com

Sponsor
Institute AstraZeneca.KK.
Institute
Department

Funding Source
Organization AstraZeneca.KK.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is planned to be a non-interventional, cross-sectional study. Approximately 500 outpatients with COPD will be recruited. Daily step counts will be measured to indicate PAL. Patient characteristics including lung functions will be recorded. In addition, physical and psychological statuses will be assessed using questionnaires including mMRC, CAT and the original questionnaire.

Management information
Registered date
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037589

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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