Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00992498

Enrollment

316

Registered

2009-10-09

Start date

2008-01-31

Completion date

2009-12-31

Last updated

2012-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD (Chronic Obstructive Pulmonary Disease), outpatients, rehabilitation, comorbidities, patient-centered outcome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Italy

Outcome results