Clinical trial NCT01608529: Feel Breathe, Restriction Device Ventilatory Nasal
Official title: Phase 1: Effects of a Restriction Device Ventilatory Nasal Flow on Pulmonary Ventilation and Gas Exchange During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mouth Breathing
Restrictive Breathing Pattern
Keywords: Restriction device ventilatory nasal flow
oronasal breathing
nasal breathing.
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Consejo Superior de Deportes, Spain
name: European Regional Development Fund
First posted: 2012-05-31
Enrollment: 27
Sex: MALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists
timeFrame: Subjects were assessed during 8 weeks
Secondary outcomes:
measure: Maximum oxygen uptake
timeFrame: Subjects were assessed during 8 weeks
measure: Maximum static inspiratory pressure (PImax)
timeFrame: Subjects were assessed during 8 weeks
Other outcomes:
Locations:
city: San Fernando
country: Spain
facility: Centro de Medicina del Deporte
state: Cadiz
Study officials:
affiliation: Universidad Complutense de Madrid
name: Jose Lopez Chicharro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cádiz (Spain)
name: Jorge dR Fernandez Santos, Phd Student
role: STUDY_CHAIR
affiliation: Universidad Complutense de Madrid
name: Davinia Vicente Campos, Phd
role: STUDY_CHAIR
affiliation: Centro de Medicina del Deporte (Cádiz)
name: Carmen Vaz Pardal, MD
role: STUDY_CHAIR
affiliation: University of Cádiz (Spain)
name: Jose L Costa Sepulveda, Phd Student
role: STUDY_CHAIR
affiliation: University of Cádiz (Spain)
name: Jose L Gonzalez Montesinos, Phd
role: STUDY_DIRECTOR
affiliation: University of Cádiz (Spain)
name: Jose Castro Piñero, Phd
role: STUDY_DIRECTOR
affiliation: University of Cádiz (Spain)
name: Julio Conde Caveda, Phd
role: STUDY_DIRECTOR
References: