Respiratory Therapy in COPD Exacerbations

Study Overview
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Brief Summary
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The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease.

Detailed Description
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Acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) is defined as an event in the natural course of the disease characterized by a change in the patient's usual symptoms (dyspnea, cough and/or sputum) that may not be explained by the daily variations and requires a change in regular medication. Because AE-COPD result in impairment of both pulmonary and respiratory muscle functions, as well as an increasing impact on costs, priority should be given to interventions to slow the progression of the disease, prevention of exacerbations and reduce the risk of comorbidity. Chest physiotherapy is often used in hospitalized patients with AE-COPD with the aim of favoring the removal of secretions and thus to improve the ventilation perfusion (V/Q), and therefore the function lung. The limited scientific evidence has determined that their use is controversial and not routinely recommended in clinical practice guidelines. Current clinical guidelines in the treatment of COPD are unable to rule on the application of respiratory therapy during exacerbations, since there is little scientific evidence of its benefits in the short and long term.

Official Title
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Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Conditions
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Obstructive Chronic Bronchitis With Acute Exacerbation

Intervention / Treatment
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* Other: No Respiratory Therapy
* Other: Respiratory Therapy


Participation Criteria
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Eligibility Criteria
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Hospitalized patients with acute exacerbation of COPD. Inclusion Criteria: age over 18 years, hospitalized patients and acute exacerbation of COPD. Exclusion Criteria: Previous history of any chronic respiratory disease and not to have performed any kind of general or respiratory training in the previous 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No Respiratory Therapy<br>Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment. | Other: No Respiratory Therapy<br>* Patients received conventional treatment.<br>|
| Experimental: Respiratory therapy<br>Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy | Other: Respiratory Therapy<br>* Respiratory Therapy consists of postural drainage, positive expiratory pressure (PEP) and vibropercussion (it is a postural drainage method, which uses chest clapping with a flexible wrist and cupped hands or a mechanical vibrator to loosen and mobilize retained secretions that can then be expectorated or drained). Postural drainage is an airways clearance technique in which patient's body is positioned so that the trachea is inclined downward and below the affected chest area. The PEP consists of expiratory cycles through a system generating a positive pressure of 10-20 cc (cubic centimeter) water. Vibropercussion is applied by the use of a mechanical system following rib movement during expiration to enhance clearance of secretions. Intervention group received 30-minute-sessions twice a day, 7 days per week, during hospitalization period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strength | Respiratory muscle strength is assessed through maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) using a pressure transducer connected to a digital register system. The MIP is measured at mouth during a maximum effort from residual volume against occluded airway. To determine the MEP, patients performed a maximum expiratory effort from total lung capacity in the face of the occluded airway. | Participants will be followed for the duration of hospital stay, an expected average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of safety and tolerability | Presence of complications and patients' satisfaction | Participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| Adverse events as a measure of safety and tolerability | Monitoring of health status and possible complications one year after discharge | One year after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory muscle training; high-intensity training