Feel Breathe, Restriction Device Ventilatory Nasal (FB)
|ClinicalTrials.gov Identifier: NCT01608529|
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : May 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Mouth Breathing Restrictive Breathing Pattern||Device: Feel Breathe, restriction device ventilatory nasal||Phase 1|
Background: Different devices are currently used to train inspiratory muscles, thus showing an increase in the physical performance. It is a control trial to investigate the effects of a new restriction and filtering device ventilatory nasal flow (FeelBreathe).
Methods: A total of 27 trained male caucasian subjects (age: 32.5 ± 7.23 years) were recruited from different sports clubs. Measurement of maximum static inspiratory pressure were taken before exercise testing and an incremental test in cycle ergometer to volitional fatigue for the determination of gas exchange data. Each subject performed three identical submaximal exercises at 50% of ventilatory thresholds under different breathing conditions: 1) oronasal breathing 2) nasal breathing and 3) nasal breathing with Feel Breathe, Restriction and Filtering Device Ventilatory Nasal Flow.
Discussion: Researchers try to find if the new device called FeelBreathe causes changes in the lung ventilation and gas exchange during exercise. If the results show altered breathing pattern and cardiometabolic variables, FeelBreathe could be used to training respiratory muscles.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1: Effects of a Restriction Device Ventilatory Nasal Flow on Pulmonary Ventilation and Gas Exchange During Exercise|
|Study Start Date :||January 2011|
|Primary Completion Date :||July 2011|
|Study Completion Date :||December 2011|
|Experimental: Cyclist group||
Device: Feel Breathe, restriction device ventilatory nasal
The Feel Breathe (FB) consisted of a small adhesive strip that is placed across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacturer'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. Each subject was required to perform three identical submaximal exercises with intensity at 50% VT1-VT2 under different breathing conditions. The breathing conditions were: oronasal, nasal and FB breathing. All participants performed three trials of stable load (50% VT1-VT2) for 10 minutes in the three conditions mentioned above, setting the cadence at 70-75 rpm, and controlling the same in all three exercise conditions.
- Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists [ Time Frame: Subjects were assessed during 8 weeks ]VE (l/min), Vtin (ml/kg), BF (bf/min), VCO2 (ml/min), VE/VO2 (ml), VE/VCO2 (ml), RER (VCO2/VO2), PETO2 (mmHg), PETCO2 (mmHg), tin (s/insp), tex (s/expir), Vtin (ml/min), Vtex (ml/min), SPO2 (%) and VO2 (ml/kg/min) were assessed throughout the exercise on a cycle ergometer (ERGO-Line GmbH + CoKG, mod. Jaeger ER-900. Germany) using three different conditions of breathing: oronasal, nasal and nasal breathing with FeelBreathe, with 10-sec sampling intervals using a open circuit spirometry (CPX Cardinal Health, 234 GmbH, Leibnizstrasse 7, D-97204 Hoechberg, Germany).
- Maximum oxygen uptake [ Time Frame: Subjects were assessed during 8 weeks ]Before experimental trials each subject performed a incremental protocol on a cycle ergometer (ERGO-Line GmbH + CoKG, mod. Jaeger ER-900. Alemania) 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 open circuit spirometry (CPX Cardinal Health, 234 GmbH, Leibnizstrasse 7, D-97204 Hoechberg, Alemania).
- Maximum static inspiratory pressure (PImax) [ Time Frame: 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%. Maximum static inspiratory pressure was measured at residual volume and the best result from three inspiratory attempts was taken. At least one minute was allowed between attempts to minimize the effects of muscle fatigue.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608529
|Centro de Medicina del Deporte|
|San Fernando, Cadiz, Spain, 11100|
|Principal Investigator:||Jose Lopez Chicharro, MD||Universidad Complutense de Madrid|
|Study Chair:||Jorge dR Fernandez Santos, Phd Student||University of Cádiz (Spain)|
|Study Chair:||Davinia Vicente Campos, Phd||Universidad Complutense de Madrid|
|Study Chair:||Carmen Vaz Pardal, MD||Centro de Medicina del Deporte (Cádiz)|
|Study Chair:||Jose L Costa Sepulveda, Phd Student||University of Cádiz (Spain)|
|Study Director:||Jose L Gonzalez Montesinos, Phd||University of Cádiz (Spain)|
|Study Director:||Jose Castro Piñero, Phd||University of Cádiz (Spain)|
|Study Director:||Julio Conde Caveda, Phd||University of Cádiz (Spain)|