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

September 10, 2020 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical activity level
Time Frame: 2 weeks
Physical activity level will be assessed as average daily duration (min) of ≧2 metabolic equivalents (METs)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Masakazu Ichinose, Professor, Tohoku University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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