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

NCT03073564 | Completed

• 1 other identifier: 15-0422
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Dyspnea; Cardiopulmonary Exercise Test; Positive-Pressure Respiration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dyspnea

  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.

  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.

Study Arms (3)

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.

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.

Diagnostic Test: Functional test

Interventions

Endurance test for upper limbs 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.

Endurance test

Functional test 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.

Functional test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Associação Fundo de Incentivo à Pesquisa: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (12)

• 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.

  PMID: 8630597 BACKGROUND

• O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. doi: 10.1080/15412550701480455.

  PMID: 17729066 BACKGROUND

• O'Donnell DE, Parker CM. COPD exacerbations . 3: Pathophysiology. Thorax. 2006 Apr;61(4):354-61. doi: 10.1136/thx.2005.041830.

  PMID: 16565268 BACKGROUND

• 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.

  PMID: 19052054 BACKGROUND

• 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.

  PMID: 19522161 BACKGROUND

• 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.

  PMID: 12684292 BACKGROUND

• 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.

  PMID: 20202941 BACKGROUND

• 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.

  PMID: 24170913 BACKGROUND

• 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.

  PMID: 22348429 BACKGROUND

• 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.

  PMID: 20500135 BACKGROUND

• 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.

  PMID: 8131541 BACKGROUND

• 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.

  PMID: 11549531 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Marli M Knorst, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 8, 2017
• Study Start: December 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: October 30, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

BR (1)