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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy
    • Clinic Center
  • Brescia
    • Lumezzane, Brescia, Italy
      • Fondazione Maugeri IRCCS
  • Modena
    • Pavullo, Modena, Italy, 41026
      • Villa Pineta Hospital
  • Pisa
    • Volterra, Pisa, Italy
      • Auxilium Vitae Rehabilitation Center
  • Roma
    • Velletri, Roma, Italy
      • Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients with or without Emphysema phenotype

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Emphysema phenotype
No-Emphysema phenotype

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnoea	Change in dyspnea grade by MRC	[ Time Frame: Day 1 and 20]
Symptoms on effort	Change in Dyspnoea and leg fatigue by Borg scale	[ Time Frame: Day 1 and 20]
Perceived Quality of life	Change in Saint George Respiratory Questionnarie (Italian version)	[ Time Frame: Day 1 and 20]
Global function	Change in the multidimensional BODE index (validated in COPD population)	[ Time Frame: Day 1 and 20]

Collaborators and Investigators

• Sponsor: Villa Pineta Hospital
• Investigators: Study Director: Enrico M Clini, MD, Villa Pineta Hospital and University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 1, 2011

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: COPD; Emphysema phenotype
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: VP-01-2011