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

NCT03642613 | Completed

• 1 other identifier: D5980R00006
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD, RWE, Physical Activity

Outcome Measures

Primary Outcomes (1)

• Physical activity level

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

  2 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients who have provided written informed consent for participation in this study
• Male and female patients aged at least 40 years at the time of enrolment who are given diagnosis of COPD by a physician\*1
• Patients whose respiratory function test values after bronchodilators (FEV1, FVC, IC) are available\*2
• Patients whose DLCO values and data on the presence/absence of emphysema by a chest CT scan are available\*3
• 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
• : Guideline 12) should be referenced for the diagnostic criteria of COPD.
• : 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.
• : This refers to patients who have undergone tests within past one year.

You may not qualify if:

• Patients who have participated in any other interventional studies such as clinical trials within the past eight weeks
• 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.
• 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.).
• Patients who require home oxygen therapy (excluding those who use it only during nighttime)

Sponsors & Collaborators

• AstraZeneca: lead
• Linical Co., Ltd.: collaborator

Study Sites (1)

Tohoku University School of Medicine

Sendai, Miyagi, 9808574, Japan

Location

Related Publications (1)

• 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.

  PMID: 33376319 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Masakazu Ichinose, Professor

  Tohoku University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 22, 2018
• Study Start: September 14, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

JP (1)