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OpenTrials
Completed

NCT Number: NCT01305668

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

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.

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Key information

Conditions

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

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Maugeri IRCCS, Lumezzane, Brescia, 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

  • 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

Treatment and study plan

Primary outcomes

  1. Exercise tolerance

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

    Change in Six minute walked distance (6MWD)

Secondary outcomes

  1. Dyspnoea

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

    Change in dyspnea grade by MRC

  2. Symptoms on effort

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

    Change in Dyspnoea and leg fatigue by Borg scale

  3. Perceived Quality of life

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

    Change in Saint George Respiratory Questionnarie (Italian version)

  4. Global function

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

    Change in the multidimensional BODE index (validated in COPD population)

Sponsors and collaborators

Lead sponsor

Villa Pineta Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2011
Registry last updated
Dec 10, 2014

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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