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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01388218
• Lead Sponsor: Barcelona Institute for Global Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2011-07-04
• Study First Posted: 2011-07-06
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2015-07
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Thorax Research Foundation; 🇬🇷 Athens, Greece

University Hospital Gasthuisberg, Katholieke Universiteit Leuven; 🇧🇪 Leuven, Belgium

Royal Brompton Hospital, Imperial College; 🇬🇧 London, England, United Kingdom

University Medical Center; 🇳🇱 Groningen, Netherlands

ELEGI/Colt laboratory UoE/MRC Centre for Inflammation Research The Queen's Medical Research Institute, University of Edinburgh; 🇬🇧 Edinburgh, Scotland, United Kingdom