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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Endurance test for upper limbs
Functional test
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Dyspnea, Cardiopulmonary Exercise Test, Positive-Pressure Respiration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Incremental cardiopulmonary test

Endurance test

Functional test

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Dynamic hyperinflation
Dynamic hypersensitivity is assessed through changes in inspiratory capacity.

Secondary Outcome Measures

Dyspnea
Dyspnea will be assessed by the Borg dispenia perception scale.
Perception of exertion in upper limbs.
Perforation of exertion in the upper limbs will be assessed through the Borg perception scale.

Full Information

First Posted
February 16, 2017
Last Updated
February 2, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT03073564
Brief Title
Effect of Expiratory Positive Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD
Official Title
Effect of Expiratory Positive Airway Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Associação Fundo de Incentivo à Pesquisa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Dyspnea, Cardiopulmonary Exercise Test, Positive-Pressure Respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The first arm of the study consists of the identification of patients who present dynamic hyperinflation (HD) through the incremental cardiopulmonary test for upper limbs. Following the HDP patients will perform a resistance test for the upper limbs with an application of EPAP. A final stage of the study will be a test for the upper limbs with an EPAP application.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incremental cardiopulmonary test
Arm Type
No Intervention
Arm Description
Incremental cardiopulmonary test for upper limbs will be performed only to identify patients who exhibit dynamic hyperinflation during upper limb exercise.
Arm Title
Endurance test
Arm Type
Experimental
Arm Description
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.
Arm Title
Functional test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Endurance test for upper limbs
Intervention Description
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
Intervention Name(s)
Functional test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dynamic hyperinflation
Description
Dynamic hypersensitivity is assessed through changes in inspiratory capacity.
Time Frame
The inspiratory capacity is assessed at rest before the cardiopulmonary exercise test (CPET) is performed, every two minutes during and immediately after the end of the test. The estimated time of the test will be 8 to 12 minutes.
Secondary Outcome Measure Information:
Title
Dyspnea
Description
Dyspnea will be assessed by the Borg dispenia perception scale.
Time Frame
Dyspnea will be evaluated at rest before the cardiopulmonary exercise test (CPET) is performed, every two minutes during and immediately after the end of the test. The estimated time of the test will be 8 to 12 minutes.
Title
Perception of exertion in upper limbs.
Description
Perforation of exertion in the upper limbs will be assessed through the Borg perception scale.
Time Frame
Perception of exertion in upper limbs will be evaluated at rest before the cardiopulmonary exercise test (CPET) is performed, every two minutes during and immediately after the end of the test. The estimated time of the test will be 8 to 12 minutes.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marli M Knorst, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

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

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