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

NCT02566915 | Unknown

• 1 other identifier: 15-0067
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Increased exercise tolerance submaximal CPET

  1 year

• Decreased dyspnea submaximal CPET

  1 year

Study Arms (2)

CPET submaximal without EPAP

NO INTERVENTION

Will be collected clinical and anthropometric data of the participants and they are packaged in self-evaluation form. Evaluation of pulmonary function at rest 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 2-3). During the visit without EPAP will be maintained using the facial mask applied without resistance.

CPET submaximal with EPAP

EXPERIMENTAL

Will be collected clinical and anthropometric data of the participants and they are packaged in self-evaluation form. Evaluation of pulmonary function at rest 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 2-3). 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. IC serial measurements will be carried out before, during and immediately after the exercise.

Device: CPET submaximal with EPAP

Interventions

CPET submaximal with EPAP DEVICE

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.

CPET submaximal with EPAP

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (18)

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• 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.

  PMID: 25302758 BACKGROUND

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  PMID: 392747 BACKGROUND

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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. doi: 10.1164/ajrccm.153.3.8630581.

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• 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 RESULT

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• 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: 10.1186/2049-6958-8-19.

  PMID: 23497658 RESULT

• 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.

  PMID: 18399861 RESULT

Related Links

• Reference values for lung function testes. I.Static volumes.
• Analysis of chest radiography of individuals with COPD and its correlation with functional testing
• Dynamic hyperinflation during treadmill exercise testing in patients with moderate to severe COPD
• Determining anaerobic threshold through heart rate variability in patients with COPD during cycloergometer exercise
• Comparison of the physiological variables in the six-minute walk test and stair-climbing test in patients with chronic obstructive pulmonary disease
• 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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Danilo C Berton

  HCPA/UFRGS

  PRINCIPAL INVESTIGATOR

• Marli M Knorst

  HCPA/UFRGS

  STUDY CHAIR

• Mariane B Monteiro

  IPA

  STUDY CHAIR

• Paulo José Z Teixeira

  Federal University of Health Science of Porto Alegre

  STUDY CHAIR

• Dulciane N Paiva

  University of Santa Cruz do Sul

  STUDY CHAIR

• Dannuey M Cardoso

  University of Santa Cruz do Sul

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: October 2, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

BR (1)