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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033888
Receipt No. R000038650
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 2018/08/28
Last modified on 2018/08/24

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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 Elucidate the actual status of levels of physical activity in patients with COPD in Japan and explore factors related to levels of physical activity in a multicenter cross-sectional study in an actual clinical setting.
Basic objectives2 Others
Basic objectives -Others 1)Compare patients in whom the level of physical activity and the respiratory function correlate with other patients for any difference in the demographic factors.
2)Investigate the actual status of levels of physical activity (step counts, activity time of each activity intensity [METs], energy expenditure, inactivity time) by patient demographic in patients with COPD.
3)Examine the degree of influence of patient demographic factors that correlate with levels of physical activity in patients with COPD.
4)Assess the relationship between the prescription status of medications (by class) and levels of physical activity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Daily step counts of patients with COPD
2)Activity time of each activity intensity (METs) in patients with COPD
3)Correlation between levels of physical activity and demographic factors in patients with COPD
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 1)Patients who have provided written informed consent for participation in this study
2)Male and female patients aged at least 40 years at the time of enrolment who are given diagnosis of COPD by a physician
3)Patients whose respiratory function test values after bronchodilators (FEV1, FVC, IC) are available
4)Patients whose DLCO values and data on the presence/absence of emphysema by a chest CT scan are available
5)Outpatients who are able to answer the questionnaires and start measurement with an activity meter within four weeks after informed consent and measure activities for 14 consecutive days
Key exclusion criteria 1)Patients who have participated in any other interventional studies such as clinical trials within the past eight weeks
2)Patients determined to be inappropriate to be enrolled in this study by investigators because they cannot comply with the procedures, limitations, and requirements of this study, or for other reasons.
3)Patients with an exacerbation of COPDa within the past eight weeks
4)Patients who require home oxygen therapy (excluding those who use it only during nighttime)
Target sample size 500

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

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Jinnai
Organization AstraZeneca.KK
Division name Medical, Evidence & Observational Research
Zip code
Address Osaka, Kita-ku, Ofuka-cho, 3-1
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 08 Month 28 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 26 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 will be conducted as a multicenter, non-interventional, cross-sectional study. Patients who have been confirmed to meet the inclusion criteria and none of the exclusion criteria of this study will be fully informed. Patients will be enrolled in the study by a continuous registration method after patients provide written informed consent. After providing informed consent, patients will answer the questionnaires and start measurement with an activity meter within four weeks. Activities will be measured for 14 consecutive days.

Management information
Registered date
2018 Year 08 Month 24 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038650

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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