Pulmonary Disease, Chronic ObstructiveNCT03073564
Effect of Expiratory Positive Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD
A study testing Endurance test for upper limbs and Functional test in people with Pulmonary Disease, Chronic Obstructive, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Endurance test for upper limbs and Functional test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2015to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: 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.
Read the 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
- Being tested
- Endurance test for upper limbs, Functional test
- Keywords
- Dyspnea, Cardiopulmonary Exercise Test, Positive-Pressure Respiration
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance test for upper limbsDiagnostic 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 testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Incremental cardiopulmonary test | No intervention | Incremental cardiopulmonary test for upper limbs will be performed only to identify patients who exhibit dynamic hyperinflation during upper limb exercise. |
| Endurance test | Experimental | 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. Receives: Diagnostic Test: Endurance test for upper limbs |
| Functional test | Experimental | 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. Receives: Diagnostic Test: Functional test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic hyperinflation
Dynamic hypersensitivity is assessed through changes in inspiratory capacity.
Measured: 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 outcomes (2)
Dyspnea
Dyspnea will be assessed by the Borg dispenia perception scale.
Measured: 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.
Perforation of exertion in the upper limbs will be assessed through the Borg perception scale.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Dec 2015
- Primary completion1 Aug 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa
- Responsible party
- Principal investigator, Dannuey Machado Cardoso, Hospital de Clinicas de Porto Alegre
- Investigators
- Marli M Knorst, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073564
- Sponsor's protocol ID
- 15-0422
- Status last verified
- Feb 2019
- First submitted
- 16 Feb 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 8630597O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. doi: 10.1080/15412550701480455.
PubMed 17729066O'Donnell DE, Parker CM. COPD exacerbations . 3: Pathophysiology. Thorax. 2006 Apr;61(4):354-61. doi: 10.1136/thx.2005.041830.
PubMed 16565268O'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.
PubMed 19052054Porto 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.
PubMed 19522161Velloso 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.
PubMed 12684292Colucci 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.
PubMed 20202941Wibmer 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.
PubMed 24170913Monteiro 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.
PubMed 22348429Padkao 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.
PubMed 20500135van 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.
PubMed 8131541O'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.
PubMed 11549531
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Expiratory Positive Airway Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD Patients
- ClinicalTrials.gov ID
- NCT03073564
- Acronym / sponsor ID
- 15-0422
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Dyspnea, Cardiopulmonary Exercise Test, Positive-Pressure Respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Incremental cardiopulmonary test | No intervention | –Incremental cardiopulmonary test for upper limbs will be performed only to identify patients who exhibit dynamic hyperinflation during upper limb exercise. |
| Endurance test | Experimental | Diagnostic Test: Endurance test for upper limbsThe 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. |
| Functional test | Experimental | Diagnostic Test: Functional testThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance test for upper limbsSubjects 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. | Diagnostic test | Endurance test |
| Functional testThe 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. | Diagnostic test | Functional test |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Background: PubMed 8630597Vestbo 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.
- Background: PubMed 17729066O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. doi: 10.1080/15412550701480455.
- Background: PubMed 16565268O'Donnell DE, Parker CM. COPD exacerbations . 3: Pathophysiology. Thorax. 2006 Apr;61(4):354-61. doi: 10.1136/thx.2005.041830.
- Background: PubMed 19052054O'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.
- Background: PubMed 19522161Porto 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.
- Background: PubMed 12684292Velloso 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.
- Background: PubMed 20202941Colucci 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.
- Background: PubMed 24170913Wibmer 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.
- Background: PubMed 22348429Monteiro 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.
- Background: PubMed 20500135Padkao 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.
- Background: PubMed 8131541van 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.
- Background: PubMed 11549531O'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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marli M Knorst, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance test for upper limbs and Functional test in people with Pulmonary Disease, Chronic Obstructive, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073564, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.