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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388218
• Other study ID #: PROactive WP4
• Status: Completed
• First received: July 4, 2011
• Last updated: April 26, 2018
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: Barcelona Institute for Global Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg, Katholieke Universiteit Leuven	Leuven
Greece	Thorax Research Foundation	Athens
Netherlands	University Medical Center	Groningen
United Kingdom	ELEGI/Colt laboratory UoE/MRC Centre for Inflammation Research The Queen's Medical Research Institute, University of Edinburgh	Edinburgh	Scotland
United Kingdom	Royal Brompton Hospital, Imperial College	London	England

Sponsors (6)

Lead Sponsor	Collaborator
Barcelona Institute for Global Health	Katholieke Universiteit Leuven, Royal Brompton & Harefield NHS Foundation Trust, University Medical Center Groningen, University of Athens, University of Edinburgh

Countries where clinical trial is conducted

Belgium,  Greece,  Netherlands,  United Kingdom, 

References & Publications (1)

Gimeno-Santos E, Raste Y, Demeyer H, Louvaris Z, de Jong C, Rabinovich RA, Hopkinson NS, Polkey MI, Vogiatzis I, Tabberer M, Dobbels F, Ivanoff N, de Boer WI, van der Molen T, Kulich K, Serra I, Basagaña X, Troosters T, Puhan MA, Karlsson N, Garcia-Aymeri — View Citation

External Links

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