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

February 22, 2016 updated by: Hospital de Clinicas de Porto Alegre

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CPET submaximal without EPAP
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.
Experimental: CPET submaximal with EPAP
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased Inspiratory Capacity (IC) through dynamic changes in lung volumes
Time Frame: 1 year

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased exercise tolerance submaximal CPET
Time Frame: 1 year
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
Decreased dyspnea submaximal CPET
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Danilo C Berton, HCPA/UFRGS
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 15-0067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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