Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992498
• Other study ID #: 02/2008
• Status: Completed
• Phase: N/A
• First received: October 7, 2009
• Last updated: December 20, 2012
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: Villa Pineta Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Italy	Clinic Center Private Hospital	Naples
Italy	Dpt.of Clinical Sciences - University of Parma	Parma
Italy	Villa Pineta Hospital - University of Modena	Pavullo nel Frignano	Modena
Italy	Cardio-Thoracic Dpt - University of Pisa -	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Villa Pineta Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Nr. patients with a minimum clinically important difference (MCID) in exercise tolerance (change in 6MWD)		T0 (admission in hospital) - Tend (discharge, after 20 days)	No
Primary	Nr. patients with a minimum clinically important difference (MCID) in breathless (change in MRC scale)		T0 (admission in hospital) - Tend (discharge, after 20 days)	No
Secondary	Percentage of patients who withdrew from rehabilitation.		Tend (discharge, after 20 days)	No
Secondary	Prevalence of comorbidities associated to COPD		Tend (discharge, after 20 days)	No