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Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Clini Enrico, Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT00992498
First received: October 7, 2009
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Villa Pineta Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients who withdrew from rehabilitation. [ Time Frame: Tend (discharge, after 20 days) ] [ Designated as safety issue: No ]
  • Prevalence of comorbidities associated to COPD [ Time Frame: Tend (discharge, after 20 days) ] [ Designated as safety issue: No ]

Enrollment: 316
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

COPD outpatients eligible for pulmonary rehabilitation

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992498

Locations
Italy
Villa Pineta Hospital - University of Modena
Pavullo nel Frignano, Modena, Italy, 41026
Clinic Center Private Hospital
Naples, Italy
Dpt.of Clinical Sciences - University of Parma
Parma, Italy
Cardio-Thoracic Dpt - University of Pisa -
Pisa, Italy
Sponsors and Collaborators
Villa Pineta Hospital
Investigators
Principal Investigator: Enrico M Clini, Prof. Villa Pineta Hospital and University of Modena
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Clini Enrico, Professor, Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT00992498     History of Changes
Other Study ID Numbers: 02/2008
Study First Received: October 7, 2009
Last Updated: December 20, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Villa Pineta Hospital:
COPD (Chronic Obstructive Pulmonary Disease)
outpatients
rehabilitation
comorbidities
patient-centered outcome

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013