Clinical trial NCT02566915: Effects of Exhalation Valve on the Lack of Air and Exercise Tolerance in Patients With COPD
Official title: Effects of Expiratory Positive Airway Pressure on Dyspnea and Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increased Inspiratory Capacity (IC) through dynamic changes in lung volumes
timeFrame: 1 year
Secondary outcomes:
measure: Increased exercise tolerance submaximal CPET
timeFrame: 1 year
measure: Decreased dyspnea submaximal CPET
timeFrame: 1 year
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: HCPA/UFRGS
name: Danilo C Berton
role: PRINCIPAL_INVESTIGATOR
affiliation: HCPA/UFRGS
name: Marli M Knorst
role: STUDY_CHAIR
affiliation: IPA
name: Mariane B Monteiro
role: STUDY_CHAIR
affiliation: Federal University of Health Science of Porto Alegre
name: Paulo José Z Teixeira
role: STUDY_CHAIR
affiliation: University of Santa Cruz do Sul
name: Dulciane N Paiva
role: STUDY_CHAIR
affiliation: University of Santa Cruz do Sul
name: Dannuey M Cardoso
role: STUDY_CHAIR
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