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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02566915
Enrollment
19
Registered
2015-10-02
Start date
2015-08-31
Completion date
2016-12-31
Last updated
2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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.

Interventions

DEVICECPET submaximal with EPAP

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.

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Increased Inspiratory Capacity (IC) through dynamic changes in lung volumes1 yearThis 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

MeasureTime frameDescription
Increased exercise tolerance submaximal CPET1 yearTo 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.
Decreased dyspnea submaximal CPET1 yearTo 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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026