Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Clini Enrico, Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT00992498
First received: October 7, 2009
Last updated: December 20, 2012
Last verified: December 2012

October 7, 2009
December 20, 2012
January 2008
December 2008   (final data collection date for primary outcome measure)
  • Nr. patients with a minimum clinically important difference (MCID) in quality of life (change in St George's Respiratory Questionnaire) [ Time Frame: T0 (admission in hospital) - Tend (discharge, after 20 days) ] [ Designated as safety issue: No ]
  • Nr. patients with a minimum clinically important difference (MCID) in exercise tolerance (change in 6MWD) [ Time Frame: T0 (admission in hospital) - Tend (discharge, after 20 days) ] [ Designated as safety issue: No ]
  • Nr. patients with a minimum clinically important difference (MCID) in breathless (change in MRC scale) [ Time Frame: T0 (admission in hospital) - Tend (discharge, after 20 days) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00992498 on ClinicalTrials.gov Archive Site
  • Percentage of patients who withdrew from rehabilitation. [ Time Frame: Tend (discharge, after 20 days) ] [ Designated as safety issue: No ]
  • Prevalence of comorbidities associated to COPD [ Time Frame: Tend (discharge, after 20 days) ] [ Designated as safety issue: No ]
Same as current
Not Provided
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Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients
Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities

A retrospective analysis on a cohort of unselected COPD patients admitted to pulmonary rehabilitation (PR) performed in one rehabilitation centre has shown that the usual program is feasible and effective even in the presence of complex comorbidities, although some combined diseases might reduce the overall proportion of patients who respond to pre-defined outcomes criteria (Crisafulli E, et al. Thorax 2008;63:487-92).

The aim of this prospective study is to describe the pattern of prevalence of the most frequently associated COPD-comorbidities and the clinical impact on rehabilitation outcomes, referred to 3 teaching and 1 private hospitals admitting for pulmonary rehabilitation purposes.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

COPD outpatients eligible for pulmonary rehabilitation

Chronic Obstructive Pulmonary Disease
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
December 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of COPD as defined and classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
  • Ability to perform a rehabilitation program.

Exclusion Criteria:

  • Patients with asthma or any other pulmonary diseases (either obstructive or restrictive.
  • Patients no able to complete a rehabilitation program
Both
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00992498
02/2008
No
Prof. Clini Enrico, Villa Pineta Hospital
Villa Pineta Hospital
Not Provided
Principal Investigator: Enrico M Clini, Prof. Villa Pineta Hospital and University of Modena
Villa Pineta Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP