Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00992498
• Lead Sponsor: Villa Pineta Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-12
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Study Completion: 2009-12
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nr. patients with a minimum clinically important difference (MCID) in quality of life (change in St George's Respiratory Questionnaire)	T0 (admission in hospital) - Tend (discharge, after 20 days)
Nr. patients with a minimum clinically important difference (MCID) in exercise tolerance (change in 6MWD)	T0 (admission in hospital) - Tend (discharge, after 20 days)
Nr. patients with a minimum clinically important difference (MCID) in breathless (change in MRC scale)	T0 (admission in hospital) - Tend (discharge, after 20 days)

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Villa Pineta Hospital - University of Modena; 🇮🇹 Pavullo nel Frignano, Modena, Italy

Clinic Center Private Hospital; 🇮🇹 Naples, Italy

Dpt.of Clinical Sciences - University of Parma; 🇮🇹 Parma, Italy

Cardio-Thoracic Dpt - University of Pisa -; 🇮🇹 Pisa, Italy