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

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

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

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

-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

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

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

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

06

Month

20

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

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 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.

Registered date

2018

Year

06

Month

13

Day

Last modified on

2018

Year

06

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037589