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

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: COPD

Treatments: Device: CPET submaximal with EPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02566915

15-0067

Details and patient eligibility

About

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).

Full 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.

Enrollment: 19 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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19 participants in 2 patient groups

CPET submaximal without EPAP

No Intervention group

Description:

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.

CPET submaximal with EPAP

Experimental group

Description:

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.

Treatment:

Device: CPET submaximal with EPAP