UMIN-CTR Clinical Trial

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

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

AstraZeneca.KK

Institute

Department

Personal name

Organization

AstraZeneca.KK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

08

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2018

Year

08

Month

24

Day

Last modified on

2018

Year

08

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038650