We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305668
First Posted: March 1, 2011
Last Update Posted: December 10, 2014
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.
Information provided by (Responsible Party):
Prof. Clini Enrico, Villa Pineta Hospital
  Purpose

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
Chronic Obstructive Pulmonary Disease Emphysema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema Phenotype

Resource links provided by NLM:


Further study details as provided by Prof. Clini Enrico, Villa Pineta Hospital:

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


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

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

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

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


Enrollment: 100
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Emphysema phenotype
No-Emphysema phenotype

  Eligibility

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.


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 Submitted: February 28, 2011
First Posted: March 1, 2011
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