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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive

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.

• Study Type: Observational
• Enrollment (Actual): 505

Contacts and Locations

Study Locations

• Japan
  • Miyagi
    • Sendai, Miyagi, Japan, 9808574
      • Tohoku University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 (forced expiratory volume in one second/forced vital capacity [FEV1/FVC] of <70% after bronchodilators within the past one year or at the time of enrolment)
3. Patients whose respiratory function test values after bronchodilators 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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	Physical activity level will be assessed as average daily duration (min) of ≧2 metabolic equivalents (METs)	2 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Linical Co., Ltd.
• Investigators: Study Chair: Masakazu Ichinose, Professor, Tohoku University School of Medicine

Publications and helpful links

General Publications

• Ichinose M, Minakata Y, Motegi T, Takahashi T, Seki M, Sugaya S, Hayashi N, Kuwahira I. A Non-Interventional, Cross-Sectional Study to Evaluate Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients with Chronic Obstructive Pulmonary Disease: STEP COPD. Int J Chron Obstruct Pulmon Dis. 2020 Dec 22;15:3385-3396. doi: 10.2147/COPD.S277782. eCollection 2020.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: COPD, RWE, Physical Activity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D5980R00006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No