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

This study is currently recruiting participants.
Verified December 2012 by Villa Pineta Hospital
Sponsor:
Information provided by (Responsible Party):
Prof. Clini Enrico, Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT01305668
First received: February 28, 2011
Last updated: December 20, 2012
Last verified: December 2012
  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)


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305668

Contacts
Contact: Enrico M Clini, MD +39053642039 enrico.clini@unimore.it

Locations
Italy
Fondazione Maugeri IRCCS Recruiting
Lumezzane, Brescia, Italy
Contact: Michele Vitacca, MD       mvitacca@fsm.it   
Villa Pineta Hospital Recruiting
Pavullo, Modena, Italy, 41026
Contact: Enrico M Clini, MD    +39053642039    enrico.clini@unimore.it   
Sub-Investigator: Ernesto Crisafulli, MD, PhD         
Sub-Investigator: Elena Venturelli, RT         
Sub-Investigator: Andrea Iattoni, MD         
Auxilium Vitae Rehabilitation Center Recruiting
Volterra, Pisa, Italy
Contact: Nicolino Ambrosino, Prof, MD       n.ambrosino@ao-pisa.toscana.it   
Sub-Investigator: Guido Vagheggini, MD         
Ospedale San Raffaele Recruiting
Velletri, Roma, Italy
Contact: Franco Pasqua, MD       franco_pasqua@fastwebnet.it   
Sub-Investigator: Gianluca Biscione, MD         
Clinic Center Recruiting
Naples, Italy
Contact: Francesco DeBlasio, MD       dicearchia@gmail.com   
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 20, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Villa Pineta Hospital:
COPD
Emphysema phenotype

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

ClinicalTrials.gov processed this record on April 14, 2014