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Clinical Trials/NCT01305668
NCT01305668CompletedNot Applicable

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

Villa Pineta Hospital5 sites in 1 country100 target enrollmentStarted: August 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
5
Primary Endpoint
Exercise tolerance

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Exercise tolerance

Time Frame: [Time Frame: Day 1 and 20 ]

Change in Six minute walked distance (6MWD)

Secondary Outcomes

  • 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])

Investigators

Sponsor
Villa Pineta Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Clini Enrico

Villa Pineta Hospital

Villa Pineta Hospital

Study Sites (5)

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