Feel Breathe, Restriction Device Ventilatory Nasal

Phase 1

Completed

• Conditions: Mouth Breathing; Restrictive Breathing Pattern
• Interventions: Device: Feel Breathe, restriction device ventilatory nasal

• Registration Number: NCT01608529
• Lead Sponsor: University of Cadiz

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 Description

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-26
• Study First Posted: 2012-05-31
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

• Age: 25-35 years.
• trained male caucasian cyclists
• Non-smokers
• Each subject completed an approved informed consent form and detailed health questionnaire before testing.

Exclusion Criteria

• Smokers.
• Presence of diseases during the test period. In particular, they had no current symptoms of nasal disease, snoring, asthma or allergic rhinitis.
• Unwillingness to complete the study requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclist group	Feel Breathe, restriction device ventilatory nasal	-

Primary Outcome Measures

Name	Time	Method
Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists	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).

Secondary Outcome Measures

Name	Time	Method
Maximum oxygen uptake	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)	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.

Trial Locations

Locations (1)

Centro de Medicina del Deporte; 🇪🇸 San Fernando, Cadiz, Spain