Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

NCT ID: NCT00992498

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

316 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COPD (Chronic Obstructive Pulmonary Disease) outpatients rehabilitation comorbidities patient-centered outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Villa Pineta Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Clini Enrico

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Enrico M Clini, Prof.

Role: PRINCIPAL_INVESTIGATOR

Villa Pineta Hospital and University of Modena

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Villa Pineta Hospital - University of Modena

Pavullo nel Frignano, Modena, Italy

Site Status

Clinic Center Private Hospital

Naples, , Italy

Site Status

Dpt.of Clinical Sciences - University of Parma

Parma, , Italy

Site Status

Cardio-Thoracic Dpt - University of Pisa -

Pisa, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18203818 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20413540 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

02/2008

Identifier Type: -

Identifier Source: org_study_id