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Feel Breathe, Restriction Device Ventilatory Nasal (FB)

Primary Purpose

Mouth Breathing, Restrictive Breathing Pattern

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Feel Breathe, restriction device ventilatory nasal
Sponsored by
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mouth Breathing focused on measuring Restriction device ventilatory nasal flow, oronasal breathing, nasal breathing.

Eligibility Criteria

25 Years - 35 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Medicina del Deporte

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclist group

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
May 17, 2012
Last Updated
May 16, 2013
Sponsor
University of Cadiz
Collaborators
Consejo Superior de Deportes, European Regional Development Fund
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1. Study Identification

Unique Protocol Identification Number
NCT01608529
Brief Title
Feel Breathe, Restriction Device Ventilatory Nasal
Acronym
FB
Official Title
Phase 1: Effects of a Restriction Device Ventilatory Nasal Flow on Pulmonary Ventilation and Gas Exchange During Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cadiz
Collaborators
Consejo Superior de Deportes, European Regional Development Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth Breathing, Restrictive Breathing Pattern
Keywords
Restriction device ventilatory nasal flow, oronasal breathing, nasal breathing.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclist group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Feel Breathe, restriction device ventilatory nasal
Other Intervention Name(s)
Restriction device ventilatory nasal. PCT/ES2010/000429., Feel Breathe. Registro: N0299875-0.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists
Description
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).
Time Frame
Subjects were assessed during 8 weeks
Secondary Outcome Measure Information:
Title
Maximum oxygen uptake
Description
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).
Time Frame
Subjects were assessed during 8 weeks
Title
Maximum static inspiratory pressure (PImax)
Description
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.
Time Frame
Subjects were assessed during 8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Lopez Chicharro, MD
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge dR Fernandez Santos, Phd Student
Organizational Affiliation
University of Cádiz (Spain)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Davinia Vicente Campos, Phd
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carmen Vaz Pardal, MD
Organizational Affiliation
Centro de Medicina del Deporte (Cádiz)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose L Costa Sepulveda, Phd Student
Organizational Affiliation
University of Cádiz (Spain)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose L Gonzalez Montesinos, Phd
Organizational Affiliation
University of Cádiz (Spain)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jose Castro Piñero, Phd
Organizational Affiliation
University of Cádiz (Spain)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julio Conde Caveda, Phd
Organizational Affiliation
University of Cádiz (Spain)
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Medicina del Deporte
City
San Fernando
State/Province
Cadiz
ZIP/Postal Code
11100
Country
Spain

12. IPD Sharing Statement

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Feel Breathe, Restriction Device Ventilatory Nasal

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