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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01388218
Enrollment
236
Registered
2011-07-06
Start date
2011-07-31
Completion date
2012-12-31
Last updated
2018-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Physical Activity, Patient Reported Outcome (PRO), Chronic obstructive pulmonary disease (COPD), Innovative Medicines Initiative - Joint Undertaking (IMI-JU)

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.

Interventions

None listed

Sponsors

KU Leuven
CollaboratorOTHER
University of Edinburgh
CollaboratorOTHER
Royal Brompton & Harefield NHS Foundation Trust
CollaboratorOTHER
University Medical Center Groningen
CollaboratorOTHER
University of Athens
CollaboratorOTHER
Barcelona Institute for Global Health
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Countries

Belgium, Greece, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026