Effects of Exhalation Valve on the Lack of Air and Exercise Tolerance in Patients With COPD

COPD Clinical Trial

Official title:

Effects of Expiratory Positive Airway Pressure on Dyspnea and Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02566915
• Other study ID #: 15-0067
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 25, 2015
• Last updated: February 22, 2016
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of the application of Expiratory Positive Airway Pressure (EPAP) on Dynamic Hyperinflation, dyspnea and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD).

Description:

Initially will be collected clinical and anthropometric data of the participants, and they are packaged in self-evaluation form. The evaluation of pulmonary function at rest (spirometry, body plethysmography and lung diffusion capacity for carbon monoxide) will be rescued from patient charts. When carried out for over six months, will be repeated by the researchers. Patients will conduct incremental CPET of 5-10W / min limited by symptoms (FEV1 <1L - 5W or FEV1> 1L - 10W) (Visit 1). After a period of 2-7 days the CPET will be performed submaximal with 75% of the peak load reached in the incremental CPET (visits 2 and 3). The application of EPAP (10cmH2O) via face mask (Vital RHDSON Signs®, New Jersey, USA) will be randomized with the help of opaque envelopes to be given in one visit. During the visit without EPAP will be maintained using the facial mask applied without resistance. IC serial measurements will be carried out before, during and immediately after the exercise. Participants will be instructed to maintain the use of long-acting bronchodilator as prescribed by the medical assistant usually before the methodological stages of the study.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 19
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• clinically stable patients without exacerbation of signs in the eight weeks preceding the study

• making use of drug therapy (long-acting bronchodilators)

• able to perform the exercise on the bike

• without other comorbidities that compromise the results exercise

• sign the Informed Consent

Exclusion Criteria:

• associated heart diseases

• diagnosis of asthma

• Oxygen therapy use

• SpO2 <85% at rest

• use of oral corticosteroids or antihistamines

• use of artificial airway

• musculoskeletal dysfunction

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• CPET submaximal with EPAP
The expiratory positive pressure is applied through silicone mask (RHDSON Vital Signs®, New Jersey, USA) containing one-way valve and a resistance mechanism expiratory positive expiratory pressure generator adjustable 5-20 cm H2O (Spring Loaded) (Vital Signs® , New Jersey, USA). The mask one headgear will be comfortably adjusted to face being used to prevent air leakage, and the pressure level gradually adjusted to the level of 10 cm H2O.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (18)

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Belman MJ, Botnick WC, Shin JW. Inhaled bronchodilators reduce dynamic hyperinflation during exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1996 Mar;153(3):967-75. — View Citation

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View Citation

Gagnon P, Guenette JA, Langer D, Laviolette L, Mainguy V, Maltais F, Ribeiro F, Saey D. Pathogenesis of hyperinflation in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014 Feb 15;9:187-201. doi: 10.2147/COPD.S38934. eCollection 2014. Review. — View Citation

Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751-8. — View Citation

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. — 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 — View Citation

Neder JA, Andreoni S, Peres C, Nery LE. Reference values for lung function tests. III. Carbon monoxide diffusing capacity (transfer factor). Braz J Med Biol Res. 1999 Jun;32(6):729-37. — View Citation

Nicolini A, Merliak F, Barlascini C. Use of positive expiratory pressure during six minute walk test: results in patients with moderate to severe chronic obstructive pulmonary disease. Multidiscip Respir Med. 2013 Mar 14;8(1):19. doi: 10.1186/2049-6958-8- — View Citation

O'Donnell DE, Gebke KB. Activity restriction in mild COPD: a challenging clinical problem. Int J Chron Obstruct Pulmon Dis. 2014 Jun 4;9:577-88. doi: 10.2147/COPD.S62766. eCollection 2014. Review. — View Citation

O'Donnell DE, Lam M, Webb KA. Measurement of symptoms, lung hyperinflation, and endurance during exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1557-65. — View Citation

O'Donnell DE, Sanii R, Giesbrecht G, Younes M. Effect of continuous positive airway pressure on respiratory sensation in patients with chronic obstructive pulmonary disease during submaximal exercise. Am Rev Respir Dis. 1988 Nov;138(5):1185-91. — View Citation

Pessoa IM, Costa D, Velloso M, Mancuzo E, Reis MA, Parreira VF. Effects of noninvasive ventilation on dynamic hiperinflation of patients with COPD during activities of daily living with upper limbs. Rev Bras Fisioter. 2012 Jan-Feb;16(1):61-7. English, Portuguese. — View Citation

Silveira L, Teixeira PJ, da Costa CC, de Souza RM, Merola PK, Colombo C, Marques RD, Berton DC. The relationship between fat-free mass index and pulmonary hyperinflation in COPD patients. Respirology. 2014 Nov;19(8):1204-8. doi: 10.1111/resp.12406. — View Citation

Soares SM, Oliveira RA, Franca SA, Rezende SM, Dragosavac D, Kacmarek RM, Carvalho CR. Continuous positive airway pressure increases inspiratory capacity of COPD patients. Respirology. 2008 May;13(3):387-93. doi: 10.1111/j.1440-1843.2008.01263.x. — View Citation

Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review. — View Citation

Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. Review. — View Citation

Yan S, Kaminski D, Sliwinski P. Reliability of inspiratory capacity for estimating end-expiratory lung volume changes during exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 Jul;156(1):55-9. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased Inspiratory Capacity (IC) through dynamic changes in lung volumes	This technique assumes that the TLC remains unchanged during exercise, even in patients with COPD: thus, changes in IC will reflect in proportional changes in end-expiratory lung volume (EELV). The validity, reproducibility and sensitivity to these interventions have been demonstrated by this technique in patients with COPD, showing a variety of functional abnormalities.; Before the test, the patients will be familiar with this technique by performing IC maneuvers. They will be instructed to breathe normally during exercise and then, through verbal commands, will conduct a deep breath followed by a relaxed expiration. During inspiration, patients will be encouraged to make every effort.; IC maneuvers are performed during the rest period are obtained until at least two reproducible efforts, namely within 10% of the highest acceptable value. After that, measurements of IC will be held every two minutes until exhaustion.	1 year	Yes
Secondary	Increased exercise tolerance submaximal CPET	To assess exercise tolerance we will compare the final time the two submaximal CPET (with EPAP and without EPAP). In each test, the patient will be encouraged to achieve maximum tolerance and will be instructed to stop the test in the exhaust.	1 year	Yes
Secondary	Decreased dyspnea submaximal CPET	To evaluate the sensation of dyspnea the year we will be using the modified Borg scale. This measurement will be held every two minutes during the two submaximal CPET (with EPAP and without EPAP).	1 year	Yes

External Links

•   Analysis of chest radiography of individuals with COPD and its correlation with functional testing
•   Comparison of the physiological variables in the six-minute walk test and stair-climbing test in patients with chronic obstructive pulmonary disease
•   Determining anaerobic threshold through heart rate variability in patients with COPD during cycloergometer exercise
•   Dynamic hyperinflation during treadmill exercise testing in patients with moderate to severe COPD
•   Effect of the continuous positive airway pressure over pulmonary volumes in chronic obstructive pulmonary disease
•   II Consenso Brasileiro sobre Doença Pulmonar Obstrutiva Crônica
•   Reference values for lung function testes. I.Static volumes.
•   Validation of the Modified Pulmonary Functional Status and Dyspnea Questionnaire and the Medical Research Council scale for use in Brazilian patients with chronic obstructive pulmonary disease