NCT00992498

Brief Summary

A retrospective analysis on a cohort of unselected COPD patients admitted to pulmonary rehabilitation (PR) performed in one rehabilitation centre has shown that the usual program is feasible and effective even in the presence of complex comorbidities, although some combined diseases might reduce the overall proportion of patients who respond to pre-defined outcomes criteria (Crisafulli E, et al. Thorax 2008;63:487-92). The aim of this prospective study is to describe the pattern of prevalence of the most frequently associated COPD-comorbidities and the clinical impact on rehabilitation outcomes, referred to 3 teaching and 1 private hospitals admitting for pulmonary rehabilitation purposes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

11 months

First QC Date

October 7, 2009

Last Update Submit

December 20, 2012

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD (Chronic Obstructive Pulmonary Disease)outpatientsrehabilitationcomorbiditiespatient-centered outcome

Outcome Measures

Primary Outcomes (3)

  • Nr. patients with a minimum clinically important difference (MCID) in quality of life (change in St George's Respiratory Questionnaire)

    T0 (admission in hospital) - Tend (discharge, after 20 days)

  • Nr. patients with a minimum clinically important difference (MCID) in exercise tolerance (change in 6MWD)

    T0 (admission in hospital) - Tend (discharge, after 20 days)

  • Nr. patients with a minimum clinically important difference (MCID) in breathless (change in MRC scale)

    T0 (admission in hospital) - Tend (discharge, after 20 days)

Secondary Outcomes (2)

  • Percentage of patients who withdrew from rehabilitation.

    Tend (discharge, after 20 days)

  • Prevalence of comorbidities associated to COPD

    Tend (discharge, after 20 days)

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD outpatients eligible for pulmonary rehabilitation

You may qualify if:

  • Presence of COPD as defined and classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
  • Ability to perform a rehabilitation program.

You may not qualify if:

  • Patients with asthma or any other pulmonary diseases (either obstructive or restrictive.
  • Patients no able to complete a rehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Villa Pineta Hospital - University of Modena

Pavullo nel Frignano, Modena, 41026, Italy

Location

Clinic Center Private Hospital

Naples, Italy

Location

Dpt.of Clinical Sciences - University of Parma

Parma, Italy

Location

Cardio-Thoracic Dpt - University of Pisa -

Pisa, Italy

Location

Related Publications (2)

  • Crisafulli E, Costi S, Luppi F, Cirelli G, Cilione C, Coletti O, Fabbri LM, Clini EM. Role of comorbidities in a cohort of patients with COPD undergoing pulmonary rehabilitation. Thorax. 2008 Jun;63(6):487-92. doi: 10.1136/thx.2007.086371. Epub 2008 Jan 18.

    PMID: 18203818RESULT

  • Crisafulli E, Gorgone P, Vagaggini B, Pagani M, Rossi G, Costa F, Guarriello V, Paggiaro P, Chetta A, de Blasio F, Olivieri D, Fabbri LM, Clini EM. Efficacy of standard rehabilitation in COPD outpatients with comorbidities. Eur Respir J. 2010 Nov;36(5):1042-8. doi: 10.1183/09031936.00203809. Epub 2010 Apr 22.

    PMID: 20413540DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Enrico M Clini, Prof.

    Villa Pineta Hospital and University of Modena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 9, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations

IT(4)