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

Completed

• Conditions: Emphysema; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01305668
• Lead Sponsor: Villa Pineta Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-01
• Study Start: 2011-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Fondazione Maugeri IRCCS; 🇮🇹 Lumezzane, Brescia, Italy

Auxilium Vitae Rehabilitation Center; 🇮🇹 Volterra, Pisa, Italy

Villa Pineta Hospital; 🇮🇹 Pavullo, Modena, Italy

Ospedale San Raffaele; 🇮🇹 Velletri, Roma, Italy

Clinic Center; 🇮🇹 Naples, Italy