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Completed

NCT Number: NCT00992498

Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

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.

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Key information

Conditions

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

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Villa Pineta Hospital - University of Modena, Pavullo nel Frignano, Modena, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

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

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

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

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

Secondary outcomes

  1. Percentage of patients who withdrew from rehabilitation.

    Time frame: Tend (discharge, after 20 days)

  2. Prevalence of comorbidities associated to COPD

    Time frame: Tend (discharge, after 20 days)

Sponsors and collaborators

Lead sponsor

Villa Pineta Hospital

Other

Registry information

Official study title

Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 9, 2009
Registry last updated
Dec 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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