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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— STEP-COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642613
• Other study ID #: D5980R00006
• Status: Completed
• Start date: September 14, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: September 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Japan	Tohoku University School of Medicine	Sendai	Miyagi

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Linical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity level	Physical activity level will be assessed as average daily duration (min) of ?2 metabolic equivalents (METs)	2 weeks

External Links

•   CSR Synopsis