Effect of Expiratory Positive Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD

NCT ID: NCT03073564

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2018-10-30

Brief Summary

The study will evaluate the effect of positive airway expiratory pressure (EPAP) on patients with chronic obstructive pulmonary disease (COPD) during submaximal upper limb exercise.

Detailed Description

The study to be developed from this project aims to evaluate the effect of positive airway expiratory pressure (EPAP) on upper limb exercise-induced dynamic hyperinflation (DH) in patients with chronic obstructive pulmonary disease (COPD). To this end, a cross-over study will be implemented, developed at the Pulmonology Department of Hospital de Clínicas de Porto Alegre. Patients with moderate to very severe, clinically stable COPD will be evaluated. The anthropometric data and pulmonary function will be collected from the medical records, being the study divided into two stages. First stage: At the first visit, dyspnea, quality of life will be evaluated and a maximal incremental cardiopulmonary exercise test (CPET) for upper limb with DH evaluation during exercise. Patients who presented DH on incremental CPET will be invited to return for a second and third visit. In the second and third visit an endurance test will be performed with 80% of the load reached in the incremental CPET and DH determination, one of the tests performed during the application of EPAP through a face mask with pressure level Of 10 cmH2O and another in usual breathing, with the mask without the use of the positive pressure generating valve. The sequence of the test, ie, with and without EPAP, will be obtained through electronic randomization. Patients completing stage 1 will be invited to enter step 2. In this step, which will occur in a single visit, patients will perform a 6-minute pegboard and ring test (6PBRT) with The same monitoring of CPET in three different situations, according to randomization: habitual breathing, half-closed lip breathing (RLS) and the EPAP mask. Thus, it is expected that the application of EPAP through face mask and the use of RLS will reduce DH during submaximal exercise with upper limb, which will be associated with the reduction of dyspnea and increased tolerance to exercise in COPD patients .

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Incremental cardiopulmonary test

Incremental cardiopulmonary test for upper limbs will be performed only to identify patients who exhibit dynamic hyperinflation during upper limb exercise.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Endurance test

The endurance test for upper limbs will be performed in two conditions: In the first the patients perform the test in usual breathing, without the use of EPAP. In the second the test will be performed using the EPAP mask.

Group Type: EXPERIMENTAL

Endurance test for upper limbs

Intervention Type: DIAGNOSTIC_TEST

Subjects will initially perform maximal incremental cardiopulmnar test of upper limbs to assess the suggestion of dynamic hyperinflation (DH). After that, it will be randomized, for those who presented DH, to perform the endurance test with and without the use of positive expiratory pressure mask.

Functional test

The functional test for upper limbs will be performed from protocol already published for the 6-min pegboard and ring test (6PBRT). In this stage the patients will perform the 6PBRT in usual breathing and as the use of the EPAP mask.

Group Type: EXPERIMENTAL

Functional test

Intervention Type: DIAGNOSTIC_TEST

The 6-min pegboard and ring test (6PBRT) will be performed under usual breathing and during application of the EPAP mask. In this condition will be evaluated the presence of dynamic hyperinflation, perception of effort and dipnea, in addition to exercise capacity.

Interventions

Endurance test for upper limbs

Subjects will initially perform maximal incremental cardiopulmnar test of upper limbs to assess the suggestion of dynamic hyperinflation (DH). After that, it will be randomized, for those who presented DH, to perform the endurance test with and without the use of positive expiratory pressure mask.

Intervention Type: DIAGNOSTIC_TEST

Functional test

The 6-min pegboard and ring test (6PBRT) will be performed under usual breathing and during application of the EPAP mask. In this condition will be evaluated the presence of dynamic hyperinflation, perception of effort and dipnea, in addition to exercise capacity.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• clinical disease stability (no signs of exacerbation within 8 weeks prior to enrollment)
• receiving standard long-term bronchodilator (BD) therapy
• able to perform cycle ergometer exercise for upper limbs

Exclusion Criteria

• use artificial airways
• severe comorbidities, such as heart, orthopedic or neurological diseases that are risky or make it impossible to exercise
• Patients on oxygen or with indication of continuous home oxygen therapy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Dannuey Machado Cardoso

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marli M Knorst, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

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Other Identifiers

15-0422

Identifier Type: -

Identifier Source: org_study_id