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Completed

NCT Number: NCT03611127

The Impact of Early Pulmonary Rehabilitation on Multidimensional Aspect of Dyspnea in COPD Patients After Exacerbation

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with severe dyspnea and exercise intolerance. Early pulmonary rehabilitation (EPR) may lead to improvements in dyspnea and exercise tolerance, as it does in stable COPD patients.

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Key information

About this study

One hundred and six patients admitted in a university hospital with AECOPD were randomized after discharge to either EPR for 8 weeks (EPR group) or usual care (UC) (UC group). All patients carried out the following initially and after 8 weeks: spirometry, 6minute walk test (SMWT), and a symptom-limited incremental cycle cardiopulmonary exercise test (CPET), and different dyspnea dimensions evaluation as following: Dyspnea intensity during incremental exercise using Borg scale, dyspnea 12 questionnaire and COPD assessment test (CAT) to assess sensory perceptual, affective distress, and symptom impact domains respectively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hospitalized COPD patients with a diagnosis of AECOPD with no clinically significant arterial hypoxemia at rest or on exercise (resting percutaneous oxygen saturation (SpO2) > 90% or a sustained decrease of < 4% during exercise) were recruited. Diagnosis of COPD, AECOPD and spirometric assessment of airflow limitation severity was based on Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Exclusion criteria

  • Patients with a prior diagnosis of other cardiorespiratory conditions (i.e., bronchial asthma, interstitial lung diseases, primary pulmonary hypertension, chronic congestive heart failure), as well as other conditions such as orthopedic, muscular and peripheral vascular diseases that could cause or contribute to breathlessness and exercise intolerance and/or could interfere with carrying out of exercise testing, were excluded.

Treatment and study plan

Pulmonary Rehabilitation

Other

pulmonary rehabilitation standardized program

Primary outcomes

  1. change in different aspects of dyspnea (dyspnea 12 questionnaire: scale range 0-36, with high score indicating worse dyspnea, and COPD assessment test: scale range 0-40, high score indicating worse dyspnea).

    Time frame: 8 weeks

    dyspnea questionnaires

  2. change in exercise performance (borg scale during incremental exercise measuring the perceived dyspnea: scale 0-10, higher score indicating worse performance

    Time frame: 8 weeks

    cardiopulmonary exercise tests

  3. change in exercise performance (test duration: longer duration measured in seconds indicating better performance)

    Time frame: 8 weeks

    cardiopulmonary exercise tests

  4. change in exercise performance (Peak oxygen consumption: Higher values indicating better performance)

    Time frame: 8 weeks

    cardiopulmonary exercise tests

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Impact of Early Pulmonary Rehabilitation on the Multidimensional Aspects of Dyspnea and Exercise Performance Following Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2018
Registry last updated
Aug 2, 2018

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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