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Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema

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ClinicalTrials.gov Identifier: NCT01305668
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation.

The phenotype evaluation in COPD patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and non-pharmacologic management of the disease.

The aim of our study is to investigate whether COPD patients with different disease phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to PR.


Condition or disease
Chronic Obstructive Pulmonary Disease Emphysema

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema Phenotype
Study Start Date : August 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Emphysema phenotype
No-Emphysema phenotype


Outcome Measures

Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: [Time Frame: Day 1 and 20 ] ]
    Change in Six minute walked distance (6MWD)


Secondary Outcome Measures :
  1. Dyspnoea [ Time Frame: [ Time Frame: Day 1 and 20] ]
    Change in dyspnea grade by MRC

  2. Symptoms on effort [ Time Frame: [ Time Frame: Day 1 and 20] ]
    Change in Dyspnoea and leg fatigue by Borg scale

  3. Perceived Quality of life [ Time Frame: [ Time Frame: Day 1 and 20] ]
    Change in Saint George Respiratory Questionnarie (Italian version)

  4. Global function [ Time Frame: [ Time Frame: Day 1 and 20] ]
    Change in the multidimensional BODE index (validated in COPD population)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients with or without Emphysema phenotype
Criteria

Inclusion Criteria:

  • COPD disease with any functional grade
  • Adherence to participate to a pulmonary rehabilitation program

Exclusion Criteria:

  • Recent acute exacerbation (4 weeks preceding enrollment)
  • Acute severe concomitant cardiovascular diseases
  • Concomitant neoplastic diseases
  • NO-Adherence to participate to a pulmonary rehabilitation program
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01305668


Locations
Italy
Fondazione Maugeri IRCCS
Lumezzane, Brescia, Italy
Villa Pineta Hospital
Pavullo, Modena, Italy, 41026
Auxilium Vitae Rehabilitation Center
Volterra, Pisa, Italy
Ospedale San Raffaele
Velletri, Roma, Italy
Clinic Center
Naples, Italy
Sponsors and Collaborators
Villa Pineta Hospital
Investigators
Study Director: Enrico M Clini, MD Villa Pineta Hospital and University of Modena and Reggio Emilia
More Information

Responsible Party: Prof. Clini Enrico, Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT01305668     History of Changes
Other Study ID Numbers: VP-01-2011
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Prof. Clini Enrico, Villa Pineta Hospital:
COPD
Emphysema phenotype

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Pulmonary Emphysema
Respiratory Tract Diseases
Pathologic Processes