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NCT01305668 Clinical Trial

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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01305668
Other study ID # VP-01-2011
Secondary ID
Status Completed
Phase N/A
First received February 28, 2011
Last updated December 9, 2014
Start date August 2011
Est. completion date December 2012

Study information
Verified date December 2014
Source Villa Pineta Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 90 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Fondazione Maugeri IRCCS Lumezzane Brescia
Italy Clinic Center Naples
Italy Villa Pineta Hospital Pavullo Modena
Italy Ospedale San Raffaele Velletri Roma
Italy Auxilium Vitae Rehabilitation Center Volterra Pisa

Sponsors (1)
Lead Sponsor Collaborator
Villa Pineta Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Exercise tolerance Change in Six minute walked distance (6MWD) [Time Frame: Day 1 and 20 ] No
Secondary Dyspnoea Change in dyspnea grade by MRC [ Time Frame: Day 1 and 20] No
Secondary Symptoms on effort Change in Dyspnoea and leg fatigue by Borg scale [ Time Frame: Day 1 and 20] No
Secondary Perceived Quality of life Change in Saint George Respiratory Questionnarie (Italian version) [ Time Frame: Day 1 and 20] No
Secondary Global function Change in the multidimensional BODE index (validated in COPD population) [ Time Frame: Day 1 and 20] No
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