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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073564
• Other study ID #: 15-0422
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: October 30, 2018

Study information

• Verified date: February 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 30, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. Review. — View Citation

O'Donnell DE, Parker CM. COPD exacerbations . 3: Pathophysiology. Thorax. 2006 Apr;61(4):354-61. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

van der Schans CP, de Jong W, de Vries G, Kaan WA, Postma DS, Koëter GH, van der Mark TW. Effects of positive expiratory pressure breathing during exercise in patients with COPD. Chest. 1994 Mar;105(3):782-9. — View Citation

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. — View Citation

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. — View Citation

Wibmer T, Rüdiger 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic hyperinflation	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	Dyspnea	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.
Secondary	Perception of exertion in upper limbs.	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.