Clinical Trial: Feel Breathe, Restriction Device Ventilatory Nasal

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 1: Effects of a Restriction Device Ventilatory Nasal Flow on Pulmonary Ventilation and Gas Exchange During Exercise

Brief Summary: It has patented a restriction and filtering device ventilatory nasal flow FeelBreathe with the aim of increase nasal airflow resistance, therefore the objective was to examine the effects of FeelBreathe with lung ventilation and gas exchange during exercise.

Detailed Summary:

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.


Sponsor: University of Cadiz

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Cadiz

Dates:
Date Received: May 17, 2012
Date Started: January 2011
Date Completion:
Last Updated: May 16, 2013
Last Verified: May 2013