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OpenTrials
Completed

NCT Number: NCT01388218

Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Barcelona Institute for Global Health

Other

Collaborators

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

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jul 6, 2011
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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