Feel Breathe, Restriction Device Ventilatory Nasal (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Other: Exercie oronasal breathing (ONB)Device: Exercie nasal breathing through the FB
- Registration Number
- NCT01695265
- Lead Sponsor
- University of Cadiz
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Exercie oronasal breathing (ONB) 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) Exercie nasal breathing through the FB 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.
- Primary Outcome Measures
Name Time Method Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD Subjects were assessed during 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Maximal Oxygen uptake Subjects were assessed during 8 weeks 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).
Maximum static inspiratory pressure (PImax) Subjects were assessed during 8 weeks 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.
Trial Locations
- Locations (1)
Centro Andaluz Medicina del Deporte
🇪🇸San Fernándo, Cádiz, Spain