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

• ClinicalTrials.gov Identifier: NCT01388218
• Recruitment Status: Completed
• First Posted: July 6, 2011
• Last Update Posted: April 27, 2018
• Sponsor: Barcelona Institute for Global Health
• Collaborators: KU Leuven; University of Edinburgh; Royal Brompton & Harefield NHS Foundation Trust; University Medical Center Groningen; University of Athens
• Information provided by (Responsible Party): Barcelona Institute for Global Health

Tracking Information

• First Submitted Date: July 4, 2011
• First Posted Date: July 6, 2011
• Last Update Posted Date: April 27, 2018
• Study Start Date: July 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)
• 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)
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Crossover; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample

Study Population

Stable COPD patients from Outpatients clinics and Primary care clinic

Exacerbated COPD patients from Inpatients

• Condition: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention: Not Provided

Study Groups/Cohorts

• Arm 1 - Daily+Clinical
  Order of assessment: Daily PRO + Clinical visit PRO
• Arm 2 - Clinical+Daily
  Order of assessment: Clinical visit PRO + Daily PRO

Publications *

• 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, Basagana X, Troosters T, Puhan MA, Karlsson N, Garcia-Aymerich J; PROactive consortium. The PROactive instruments to measure physical activity in patients with chronic obstructive pulmonary disease. Eur Respir J. 2015 Oct;46(4):988-1000. doi: 10.1183/09031936.00183014. Epub 2015 May 28.
• Demeyer H, Gimeno-Santos E, Rabinovich RA, Hornikx M, Louvaris Z, de Boer WI, Karlsson N, de Jong C, Van der Molen T, Vogiatzis I, Janssens W, Garcia-Aymerich J, Troosters T, Polkey MI; PROactive consortium. Physical Activity Characteristics across GOLD Quadrants Depend on the Questionnaire Used. PLoS One. 2016 Mar 14;11(3):e0151255. doi: 10.1371/journal.pone.0151255. eCollection 2016.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 29, 2013): 236
• Original Estimated Enrollment (submitted: July 4, 2011): 280
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Greece, Netherlands, United Kingdom

Administrative Information

• NCT Number: NCT01388218
• Other Study ID Numbers: PROactive WP4
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Barcelona Institute for Global Health
• Original Responsible Party: Judith Garcia-Aymerich, Centre for Research in Environmental Epidemiology, Spain
• Current Study Sponsor: Barcelona Institute for Global Health
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Study Chair: Judith Garcia-Aymerich, MD, PhD; Barcelona Institute for Global Health
• 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

• PRS Account: Barcelona Institute for Global Health
• Verification Date: July 2015