Feel Breathe, Restriction Device Ventilatory Nasal (COPD) (BreatheCOPD)

FEELBREATHE®, a nasal ventilatory restriction device, used during an exercise test in treadmill produces changes on breathing efficiency in patients with Chronic Obstructive Pulmonary Disease (COPD). 20 men with COPD with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. Then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. During the second day, each participant conducted two tests with 30 min of rest between them. Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing through the FB.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Exercie oronasal breathing (ONB); Device: Exercie nasal breathing through the FB

Detailed Description

Rationale: A device called FeelBreahte (FB)® has been designed, developed and patented for inspiratory muscle training in dynamic situations.

Objetive: To examine the effects of FB on lung ventilation, gas exchange and heart rate during exercise in patients with COPD.

Methods: 20 men with COPD with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. In the first visit to the laboratory, baseline static maximum inspiratory pressure and spirometry were performed previous to the exercise. Then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. During the second day, each participant conducted two tests with 30 min of rest between them. Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing through the FB.

Results: Lung ventilation and gas exchange during exercise in COPD patients was modified during exercise using FB. Our results showed a positive effects of FB vs ONB on dynamic hyperinflation, an improved breathing pattern and breathing efficiency, higher expiratory and inspiratory time and higher perceived effort. Despite these differences, blood oxygen saturation percentage, oxygen uptake and heart rate showed similar response between both conditions.

Conclusions: The new device FB used during exercise in COPD patients influenced ventilatory responses to an efficiency breathing compared to oronasal mode.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cádiz
    • San Fernándo, Cádiz, Spain, 11100
      • Centro Andaluz Medicina del Deporte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients diagnosed of Chronic Obstructive Pulmonary Disease (COPD) at least 6 months before, with a forced expiratory volume in the first second (FEV1) between 70 and 30% of predicted value

Exclusion Criteria:

• Suffer other illness.
• Unwillingness to complete the study requirements.
• Cardiovascular diseases (resting electrocardiogram and during exercise).
• Elevated resting blood pressure (>130/85 mmHg). All inclusion and exclusion criteria were assessed by a detailed medical history and, where noted, by specific measurements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercie oronasal breathing (ONB); Exercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with oronasal breathing (ONB) (Without FeelBreathe device)	Other: Exercie oronasal breathing (ONB); 10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using oronasal breathing (ONB)
EXPERIMENTAL: Exercie nasal breathing through the FB; Exercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with nasal restriction using FeelBreathe device.	Device: Exercie nasal breathing through the FB; Device: Feel Breathe, restriction device ventilatory nasal The Feel Breathe (FB) consisted of a small adhesive strip that is place across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacture's directions, while the placebo nasal, was placed over the nostrils of the subject, without interfering nasal breathing; thus, nasal airflow resistance was not increase. 10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using FeelBreathe device (FB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD	The investigators measure minute ventilation, peak oxygen uptake (VO2p), peak carbon dioxide production (VCO2p), breathing frequency (BF), ventilatory equivalent for carbon dioxide (CO2 Eq), ventilatory equivalent for oxygen (Eq O2), expiratory tidal volume (Vtexp), inspiratory tidal volume (Vtins), end-tidal carbon dioxide tension (PETCO2), end-tidal oxygen tension (PETO2), inspiratory time (T.in), ratio of inspiratory duration to total breath duration (ti/t), expiratory time (Tex), oxygen saturation measure by pulse-oximetry SpO2), heart rate (HR), duration of the test and dyspnea and leg fatigue measures by Borg scale. Each subject performed two identical submaximal exercises at 50% of VO2peak under different breathing conditions: 1) nasal breathing with FB and 2) oronasal breathing without FB. Incremental exercise tests were performed on a treadmill ergometer using a one minute step protocol to a symptom-limited maximum.	Subjects were assessed during 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Oxygen uptake	Before experimental trials each subject performed an incremental protocol on a treadmill ergometer (MONARK, Hamburg, Germany) for the determination of gas exchange. The test was stopped upon volitional fatigue of the subject. Gas-exchange data were measured breath by breath using an Oxycon cardiopulmonary exercise system (Jaeger, Hoechberg, Germany).	Subjects were assessed during 8 weeks
Maximum static inspiratory pressure (PImax)	Inspiratory muscle testing was performed using a mouth pressure meter (Micro Medical Inc., Chatham, Kent, UK). The manufacturer states that the test-retest reliability of this device is ±3%. PImax was measured at residual volume and the best result from three inspiratory attempts was taken. Al least one minute was allowed between attempts to minimize the effects of muscle fatigue.	Subjects were assessed during 8 weeks

Collaborators and Investigators

• Sponsor: University of Cadiz
• Collaborators: European Regional Development Fund
• Investigators: Study Director: Aurelio Arnedillo Muñoz, PhD, Hospital Puerta del Mar Cádiz Spain; Study Director: Carmen Vaz Pardal, MD, Centro de Medicina del Deporte. Junta de Andalucía. Cádiz; Study Director: Jose Lopez Chicharro, PhD, Universidad Autonoma de Madrid; Study Chair: Pelayo Arroyo García, PhD, University of Cadiz; Study Director: Jose Castro Piñero, PhD, University of Cadiz; Study Chair: Jorge dR Fernández Santos, PhD Student, University of Cadiz; Principal Investigator: José L. González Montesinos, PhD, University of Cadiz; Study Chair: Julio Conde Caveda, PhD, University of Cadiz; Study Director: Jesús G Ponce González, PhD, University of Cadiz

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (ESTIMATE): September 27, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Airflow Obstruction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: AC26392COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All researchers included in this study could access to the database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No