- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03073564
Effect of Expiratory Positive Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD
February 2, 2019 updated by: Dannuey Machado Cardoso, Hospital de Clinicas de Porto Alegre
Effect of Expiratory Positive Airway Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 .
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Incremental cardiopulmonary test
Incremental cardiopulmonary test for upper limbs will be performed only to identify patients who exhibit dynamic hyperinflation during upper limb exercise.
|
|
EXPERIMENTAL: 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.
|
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.
|
EXPERIMENTAL: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic hyperinflation
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.
|
Dynamic hypersensitivity is assessed through changes in inspiratory capacity.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
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.
|
Dyspnea will be assessed by the Borg dispenia perception scale.
|
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.
|
Perception of exertion in upper limbs.
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.
|
Perforation of exertion in the upper limbs will be assessed through the Borg perception scale.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marli M Knorst, PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
- Vestbo J, Prescott E, Lange P. Association of chronic mucus hypersecretion with FEV1 decline and chronic obstructive pulmonary disease morbidity. Copenhagen City Heart Study Group. Am J Respir Crit Care Med. 1996 May;153(5):1530-5. doi: 10.1164/ajrccm.153.5.8630597.
- O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. doi: 10.1080/15412550701480455.
- O'Donnell DE, Parker CM. COPD exacerbations . 3: Pathophysiology. Thorax. 2006 Apr;61(4):354-61. doi: 10.1136/thx.2005.041830.
- O'Donnell DE, Laveneziana P, Ora J, Webb KA, Lam YM, Ofir D. Evaluation of acute bronchodilator reversibility in patients with symptoms of GOLD stage I COPD. Thorax. 2009 Mar;64(3):216-23. doi: 10.1136/thx.2008.103598. Epub 2008 Dec 3.
- Porto EF, Castro AA, Velloso M, Nascimento O, Dal Maso F, Jardim JR. Exercises using the upper limbs hyperinflate COPD patients more than exercises using the lower limbs at the same metabolic demand. Monaldi Arch Chest Dis. 2009 Mar;71(1):21-6. doi: 10.4081/monaldi.2009.372.
- Velloso M, Stella SG, Cendon S, Silva AC, Jardim JR. Metabolic and ventilatory parameters of four activities of daily living accomplished with arms in COPD patients. Chest. 2003 Apr;123(4):1047-53. doi: 10.1378/chest.123.4.1047.
- Colucci M, Cortopassi F, Porto E, Castro A, Colucci E, Iamonti VC, Souza G, Nascimento O, Jardim JR. Upper limb exercises using varied workloads and their association with dynamic hyperinflation in patients with COPD. Chest. 2010 Jul;138(1):39-46. doi: 10.1378/chest.09-2878. Epub 2010 Mar 4.
- Wibmer T, Rudiger S, Heitner C, Kropf-Sanchen C, Blanta I, Stoiber KM, Rottbauer W, Schumann C. Effects of nasal positive expiratory pressure on dynamic hyperinflation and 6-minute walk test in patients with COPD. Respir Care. 2014 May;59(5):699-708. doi: 10.4187/respcare.02668. Epub 2013 Oct 29.
- Monteiro MB, Berton DC, Moreira MA, Menna-Barreto SS, Teixeira PJ. Effects of expiratory positive airway pressure on dynamic hyperinflation during exercise in patients with COPD. Respir Care. 2012 Sep;57(9):1405-12. doi: 10.4187/respcare.01481. Epub 2012 Feb 17.
- Padkao T, Boonsawat W, Jones CU. Conical-PEP is safe, reduces lung hyperinflation and contributes to improved exercise endurance in patients with COPD: a randomised cross-over trial. J Physiother. 2010;56(1):33-9. doi: 10.1016/s1836-9553(10)70052-7.
- van der Schans CP, de Jong W, de Vries G, Kaan WA, Postma DS, Koeter GH, van der Mark TW. Effects of positive expiratory pressure breathing during exercise in patients with COPD. Chest. 1994 Mar;105(3):782-9. doi: 10.1378/chest.105.3.782.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2015
Primary Completion (ACTUAL)
August 1, 2018
Study Completion (ACTUAL)
October 30, 2018
Study Registration Dates
First Submitted
February 16, 2017
First Submitted That Met QC Criteria
March 2, 2017
First Posted (ACTUAL)
March 8, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 5, 2019
Last Update Submitted That Met QC Criteria
February 2, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-0422
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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