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Clinical Trials/NCT00992498
NCT00992498
Completed
Not Applicable

Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities

Villa Pineta Hospital4 sites in 1 country316 target enrollmentJanuary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Villa Pineta Hospital
Enrollment
316
Locations
4
Primary Endpoint
Nr. patients with a minimum clinically important difference (MCID) in quality of life (change in St George's Respiratory Questionnaire)
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
December 2009
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Villa Pineta Hospital
Responsible Party
Principal Investigator
Principal Investigator

Prof. Clini Enrico

Professor

Villa Pineta Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

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)

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)

Secondary Outcomes

  • Percentage of patients who withdrew from rehabilitation.(Tend (discharge, after 20 days))
  • Prevalence of comorbidities associated to COPD(Tend (discharge, after 20 days))

Study Sites (4)

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