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

NCT01305668 | Completed

• 1 other identifier: VP-01-2011
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Obstructive Pulmonary Disease; Emphysema

Keywords

COPD; Emphysema phenotype

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  Change in Six minute walked distance (6MWD)

  [Time Frame: Day 1 and 20 ]

Secondary Outcomes (4)

• Dyspnoea

  [ Time Frame: Day 1 and 20]

• Symptoms on effort

  [ Time Frame: Day 1 and 20]

• Perceived Quality of life

  [ Time Frame: Day 1 and 20]

• Global function

  [ Time Frame: Day 1 and 20]

Study Arms (2)

Emphysema phenotype

No-Emphysema phenotype

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients with or without Emphysema phenotype

You may qualify if:

• COPD disease with any functional grade
• Adherence to participate to a pulmonary rehabilitation program

You may not qualify if:

• Recent acute exacerbation (4 weeks preceding enrollment)
• Acute severe concomitant cardiovascular diseases
• Concomitant neoplastic diseases
• NO-Adherence to participate to a pulmonary rehabilitation program

Sponsors & Collaborators

• Villa Pineta Hospital: lead

Study Sites (5)

Fondazione Maugeri IRCCS

Lumezzane, Brescia, Italy

Location

Villa Pineta Hospital

Pavullo nel Frignano, Modena, 41026, Italy

Location

Auxilium Vitae Rehabilitation Center

Volterra, Pisa, Italy

Location

Ospedale San Raffaele

Velletri, Roma, Italy

Location

Clinic Center

Naples, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico M Clini, MD

  Villa Pineta Hospital and University of Modena and Reggio Emilia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Villa Pineta Hospital

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

IT (5)