Clinical trial NCT00992498: Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients
Official title: Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD (Chronic Obstructive Pulmonary Disease)
outpatients
rehabilitation
comorbidities
patient-centered outcome
Lead sponsor: Villa Pineta Hospital
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 316
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD outpatients eligible for pulmonary rehabilitation

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.


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

Primary outcomes:
measure: Nr. patients with a minimum clinically important difference (MCID) in quality of life (change in St George's Respiratory Questionnaire)
timeFrame: T0 (admission in hospital) - Tend (discharge, after 20 days)
measure: Nr. patients with a minimum clinically important difference (MCID) in exercise tolerance (change in 6MWD)
timeFrame: T0 (admission in hospital) - Tend (discharge, after 20 days)
measure: Nr. patients with a minimum clinically important difference (MCID) in breathless (change in MRC scale)
timeFrame: T0 (admission in hospital) - Tend (discharge, after 20 days)
Secondary outcomes:
measure: Percentage of patients who withdrew from rehabilitation.
timeFrame: Tend (discharge, after 20 days)
measure: Prevalence of comorbidities associated to COPD
timeFrame: Tend (discharge, after 20 days)
Other outcomes:
Locations:
city: Pavullo nel Frignano
country: Italy
facility: Villa Pineta Hospital - University of Modena
state: Modena
city: Naples
country: Italy
facility: Clinic Center Private Hospital
city: Parma
country: Italy
facility: Dpt.of Clinical Sciences - University of Parma
city: Pisa
country: Italy
facility: Cardio-Thoracic Dpt - University of Pisa -
Study officials:
affiliation: Villa Pineta Hospital and University of Modena
name: Enrico M Clini, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crisafulli E, Costi S, Luppi F, Cirelli G, Cilione C, Coletti O, Fabbri LM, Clini EM. Role of comorbidities in a cohort of patients with COPD undergoing pulmonary rehabilitation. Thorax. 2008 Jun;63(6):487-92. doi: 10.1136/thx.2007.086371. Epub 2008 Jan 18.
citation: Crisafulli E, Gorgone P, Vagaggini B, Pagani M, Rossi G, Costa F, Guarriello V, Paggiaro P, Chetta A, de Blasio F, Olivieri D, Fabbri LM, Clini EM. Efficacy of standard rehabilitation in COPD outpatients with comorbidities. Eur Respir J. 2010 Nov;36(5):1042-8. doi: 10.1183/09031936.00203809. Epub 2010 Apr 22.