UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A non-interventional, cross-sectional study for evaluating factors relating to daily step counts and physical activity in Japanese patients with COPD
Title of the study (Brief title)	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	Shigetaka Kouda
Organization	AstraZeneca.KK.
Division name	Medical
Address	3-1, Ofuna-cho, Kita-ku, Osaka
TEL	06-7711-3714
Email	Tatsunori.Jinnai@astrazeneca.com

Public contact
Name of contact person	Tatsunori Jinnai
Organization	AstraZeneca.KK.
Division name	Medical
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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