Effects of Exhalation Valve on the Lack of Air and Exercise Tolerance in Patients With COPD

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of the application of Expiratory Positive Airway Pressure (EPAP) on Dynamic Hyperinflation, dyspnea and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description
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Initially will be collected clinical and anthropometric data of the participants, and they are packaged in self-evaluation form. The evaluation of pulmonary function at rest (spirometry, body plethysmography and lung diffusion capacity for carbon monoxide) will be rescued from patient charts. When carried out for over six months, will be repeated by the researchers. Patients will conduct incremental CPET of 5-10W / min limited by symptoms (FEV1 <1L - 5W or FEV1> 1L - 10W) (Visit 1). After a period of 2-7 days the CPET will be performed submaximal with 75% of the peak load reached in the incremental CPET (visits 2 and 3). The application of EPAP (10cmH2O) via face mask (Vital RHDSON Signs®, New Jersey, USA) will be randomized with the help of opaque envelopes to be given in one visit. During the visit without EPAP will be maintained using the facial mask applied without resistance. IC serial measurements will be carried out before, during and immediately after the exercise. Participants will be instructed to maintain the use of long-acting bronchodilator as prescribed by the medical assistant usually before the methodological stages of the study.

Official Title
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Effects of Expiratory Positive Airway Pressure on Dyspnea and Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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COPD

Intervention / Treatment
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* Device: CPET submaximal with EPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically stable patients without exacerbation of signs in the eight weeks preceding the study making use of drug therapy (long-acting bronchodilators) able to perform the exercise on the bike without other comorbidities that compromise the results exercise sign the Informed Consent Exclusion Criteria: associated heart diseases diagnosis of asthma Oxygen therapy use SpO2 <85% at rest use of oral corticosteroids or antihistamines use of artificial airway musculoskeletal dysfunction

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CPET submaximal without EPAP<br>Will be collected clinical and anthropometric data of the participants and they are packaged in self-evaluation form. Evaluation of pulmonary function at rest will be rescued from patient charts. When carried out for over six months, will be repeated by the researchers. Patients will conduct incremental CPET of 5-10W/min limited by symptoms (FEV1 <1L-5W or FEV1> 1L-10W) (Visit 1). After a period of 2-7 days the CPET will be performed submaximal with 75% of the peak load reached in the incremental CPET (visits 2-3). During the visit without EPAP will be maintained using the facial mask applied without resistance. | |
| Experimental: CPET submaximal with EPAP<br>Will be collected clinical and anthropometric data of the participants and they are packaged in self-evaluation form. Evaluation of pulmonary function at rest will be rescued from patient charts. When carried out for over six months, will be repeated by the researchers. Patients will conduct incremental CPET of 5-10W/min limited by symptoms (FEV1 <1L-5W or FEV1> 1L-10W) (Visit 1). After a period of 2-7 days the CPET will be performed submaximal with 75% of the peak load reached in the incremental CPET (visits 2-3). The application of EPAP (10cmH2O) via face mask (Vital RHDSON Signs®, New Jersey, USA) will be randomized with the help of opaque envelopes to be given in one visit. IC serial measurements will be carried out before, during and immediately after the exercise. | Device: CPET submaximal with EPAP<br>* The expiratory positive pressure is applied through silicone mask (RHDSON Vital Signs®, New Jersey, USA) containing one-way valve and a resistance mechanism expiratory positive expiratory pressure generator adjustable 5-20 cm H2O (Spring Loaded) (Vital Signs® , New Jersey, USA). The mask one headgear will be comfortably adjusted to face being used to prevent air leakage, and the pressure level gradually adjusted to the level of 10 cm H2O.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased Inspiratory Capacity (IC) through dynamic changes in lung volumes | This technique assumes that the TLC remains unchanged during exercise, even in patients with COPD: thus, changes in IC will reflect in proportional changes in end-expiratory lung volume (EELV). The validity, reproducibility and sensitivity to these interventions have been demonstrated by this technique in patients with COPD, showing a variety of functional abnormalities. Before the test, the patients will be familiar with this technique by performing IC maneuvers. They will be instructed to breathe normally during exercise and then, through verbal commands, will conduct a deep breath followed by a relaxed expiration. During inspiration, patients will be encouraged to make every effort. IC maneuvers are performed during the rest period are obtained until at least two reproducible efforts, namely within 10% of the highest acceptable value. After that, measurements of IC will be held every two minutes until exhaustion. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased exercise tolerance submaximal CPET | To assess exercise tolerance we will compare the final time the two submaximal CPET (with EPAP and without EPAP). In each test, the patient will be encouraged to achieve maximum tolerance and will be instructed to stop the test in the exhaust. | 1 year | 
| Decreased dyspnea submaximal CPET | To evaluate the sensation of dyspnea the year we will be using the modified Borg scale. This measurement will be held every two minutes during the two submaximal CPET (with EPAP and without EPAP). | 1 year |