Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

April 26, 2018 updated by: Barcelona Institute for Global Health

Non-interventional Cross-over Study to Reduce Items of the Draft PROactive Tools as a Measure of Physical Activity in Daily Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the protocol is to develop final draft PRO instruments of physical activity in daily life to be used and evaluated in the further validation studies measuring physical activity in chronic obstructive pulmonary disease (COPD) patients.

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.

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.
236

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

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Gasthuisberg, Katholieke Universiteit Leuven
  • Greece
      • Athens, Greece
        • Thorax Research Foundation
  • Netherlands
      • Groningen, Netherlands
        • University Medical Center
  • United Kingdom
    • England
      • London, England, United Kingdom, SW3 6NP
        • Royal Brompton Hospital, Imperial College
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4TJ
        • ELEGI/Colt laboratory UoE/MRC Centre for Inflammation Research The Queen's Medical Research Institute, University of Edinburgh

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

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Stable COPD patients from Outpatients clinics and Primary care clinic

Exacerbated COPD patients from Inpatients

Description

Inclusion Criteria:

  • Diagnosis of COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria: post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)<70%) confirmed with spirometry in stable clinical conditions. For patients recruited during an exacerbation, the diagnosis of COPD should be confirmed in stable conditions.
  • Current or ex-smokers with a smoking history equivalent to at least 10 pack years.
  • Able to read and write and to use electronic devices and physical activity monitor.

Exclusion Criteria:

  • Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator.
  • Respiratory diseases other than COPD (e.g. asthma).
  • Cognitive impairment, as judged by the investigator

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Arm 1 - Daily+Clinical
Order of assessment: Daily PRO + Clinical visit PRO
Arm 2 - Clinical+Daily
Order of assessment: Clinical visit PRO + Daily PRO

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.
Barcelona Institute for Global Health

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.
KU Leuven
University Medical Center Groningen
University of Athens
University of Edinburgh
Royal Brompton & Harefield NHS Foundation Trust

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: Niklas Karlsson, AstraZeneca
  • Principal Investigator: Thierry Troosters, KUL Leuven
  • Principal Investigator: Thys van der Molen, University Medical Center Groningen
  • Principal Investigator: Nick Hopkinson, MD, Imperial College London
  • Principal Investigator: Roberto Rabinovich, MD, PhD, University of Edinburgh
  • Principal Investigator: Ioannis Vogiatzis, PhD, Thorax Research Foundation Athens

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

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.
July 1, 2011

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.
December 1, 2011

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.
December 1, 2012

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).
July 4, 2011

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.
July 4, 2011

First Posted (Estimate)

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.
July 6, 2011

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.
April 27, 2018

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.
April 26, 2018

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.
July 1, 2015

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.
  • PROactive WP4

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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