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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Clini Enrico, Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT01305668
First received: February 28, 2011
Last updated: December 9, 2014
Last verified: December 2014
  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 Villa Pineta Hospital:

Primary Outcome Measures:
  • Exercise tolerance [ Time Frame: [Time Frame: Day 1 and 20 ] ] [ Designated as safety issue: No ]
    Change in Six minute walked distance (6MWD)


Secondary Outcome Measures:
  • Dyspnoea [ Time Frame: [ Time Frame: Day 1 and 20] ] [ Designated as safety issue: No ]
    Change in dyspnea grade by MRC

  • Symptoms on effort [ Time Frame: [ Time Frame: Day 1 and 20] ] [ Designated as safety issue: No ]
    Change in Dyspnoea and leg fatigue by Borg scale

  • Perceived Quality of life [ Time Frame: [ Time Frame: Day 1 and 20] ] [ Designated as safety issue: No ]
    Change in Saint George Respiratory Questionnarie (Italian version)

  • Global function [ Time Frame: [ Time Frame: Day 1 and 20] ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof. Clini Enrico, Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT01305668     History of Changes
Other Study ID Numbers: VP-01-2011
Study First Received: February 28, 2011
Last Updated: December 9, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Villa Pineta Hospital:
COPD
Emphysema phenotype

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

ClinicalTrials.gov processed this record on July 28, 2015