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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

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

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
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

Barcelona Institute for Global Health

Collaborators

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

Investigators

  • 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

July 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 4, 2011

First Submitted That Met QC Criteria

July 4, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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