Working… Menu

Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992498
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : December 21, 2012
Information provided by (Responsible Party):
Prof. Clini Enrico, 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.

Condition or disease
Chronic Obstructive Pulmonary Disease

Layout table for study information
Study Type : Observational
Actual Enrollment : 316 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]

Secondary Outcome Measures :
  1. Percentage of patients who withdrew from rehabilitation. [ Time Frame: Tend (discharge, after 20 days) ]
  2. Prevalence of comorbidities associated to COPD [ Time Frame: Tend (discharge, after 20 days) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD outpatients eligible for pulmonary rehabilitation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00992498

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Enrico M Clini, Prof. Villa Pineta Hospital and University of Modena
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof. Clini Enrico, Professor, Villa Pineta Hospital Identifier: NCT00992498    
Other Study ID Numbers: 02/2008
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012
Keywords provided by Prof. Clini Enrico, Villa Pineta Hospital:
COPD (Chronic Obstructive Pulmonary Disease)
patient-centered outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases