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The Study for Evaluating Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients With COPD.

A Non-interventional, Cross-sectional Study for Evaluating Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients With COPD.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03642613
Acronym
STEP-COPD
Enrollment
505
Registered
2018-08-22
Start date
2018-09-14
Completion date
2019-03-15
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD, RWE, Physical Activity

Brief summary

This study is conducted as a multicenter, non-interventional, cross-sectional study. 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 accelerometer within four weeks. Activities will be measured for 14 consecutive days.

Detailed description

This study is conducted as a multicenter, non-interventional, cross-sectional study. 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 accelerometer within four weeks. Activities will be measured for 14 consecutive days. \<Objectives\> * Evaluation of factors relating to physical activity level in COPD patients. * 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.

Interventions

None listed

Sponsors

Linical Co., Ltd.
CollaboratorINDUSTRY
AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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\*1 3. Patients whose respiratory function test values after bronchodilators (FEV1, FVC, IC) are available\*2 4. Patients whose DLCO values and data on the presence/absence of emphysema by a chest CT scan are available\*3 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 * 1: Guideline 12) should be referenced for the diagnostic criteria of COPD. * 2: Patients whose respiratory function test values after bronchodilators at the time of enrolment or within three months prior to enrolment are available. For patients on a bronchodilator as a long-term controller, respiratory function test values after bronchodilator in the morning of the test are acceptable. * 3: This refers to patients who have undergone tests within past one year.

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 a Exacerbation of COPD: Conditions with increased shortness of breath, increased cough and sputum, occurrence of chest discomfort/uneasiness or its intensification, and which require changes in treatment on disease stable state, excluding cases where there is any other precedent disease (heart failure, pneumothorax, pulmonary thromboembolism, etc.). 4. Patients who require home oxygen therapy (excluding those who use it only during nighttime)

Design outcomes

Primary

MeasureTime frameDescription
Physical activity level2 weeksPhysical activity level will be assessed as average daily duration (min) of ≧2 metabolic equivalents (METs)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026