Feel Breathe, Restriction Device Ventilatory Nasal (FB)
This study has been completed.
Sponsor:
University of Cadiz
Collaborators:
Universidad de Cádiz
Consejo Superior de Deportes
Fondo Europeo de Desarrollo Regional
Information provided by (Responsible Party):
University of Cadiz
ClinicalTrials.gov Identifier:
NCT01608529
First received: May 17, 2012
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mouth Breathing Restrictive Breathing Pattern |
Device: Feel Breathe, restriction device ventilatory nasal |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1: Effects of a Restriction Device Ventilatory Nasal Flow on Pulmonary Ventilation and Gas Exchange During Exercise |
Resource links provided by NLM:
Further study details as provided by University of Cadiz:
Primary Outcome Measures:
- Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists [ Time Frame: Subjects were assessed during 8 weeks ] [ Designated as safety issue: No ]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:
- Maximum oxygen uptake [ Time Frame: Subjects were assessed during 8 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 27 |
| Study Start Date: | January 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
Other Names:
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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| Ages Eligible for Study: | 25 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608529
Locations
| Spain | |
| Centro de Medicina del Deporte | |
| San Fernando, Cadiz, Spain, 11100 | |
Sponsors and Collaborators
University of Cadiz
Universidad de Cádiz
Consejo Superior de Deportes
Fondo Europeo de Desarrollo Regional
Investigators
| 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) |
More Information
No publications provided
| Responsible Party: | University of Cadiz |
| ClinicalTrials.gov Identifier: | NCT01608529 History of Changes |
| Other Study ID Numbers: | AC26392 |
| Study First Received: | May 17, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by University of Cadiz:
|
Restriction device ventilatory nasal flow oronasal breathing nasal breathing. |
Additional relevant MeSH terms:
|
Respiratory Aspiration Mouth Breathing Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013