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

Not Applicable

• Conditions: COPD
• Interventions: Device: CPET submaximal with EPAP

• Registration Number: NCT02566915
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPET submaximal with EPAP	CPET submaximal with EPAP	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.

Primary Outcome Measures

Name	Time	Method
Increased Inspiratory Capacity (IC) through dynamic changes in lung volumes	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Decreased dyspnea submaximal CPET	1 year	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).
Increased exercise tolerance submaximal CPET	1 year	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.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil