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

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ClinicalTrials.gov Identifier: NCT01388218
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : April 27, 2018
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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