Clinical trial NCT01695265: Feel Breathe, Restriction Device Ventilatory Nasal (COPD)
Official title: Feel Breathe, Restriction Device Ventilatory Nasal (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Airflow Obstruction
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
First posted: 2012-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: FEELBREATHE®, a nasal ventilatory restriction device, used during an exercise test in treadmill produces changes on breathing efficiency in patients with Chronic Obstructive Pulmonary Disease (COPD). 20 men with COPD with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. Then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. During the second day, each participant conducted two tests with 30 min of rest between them. Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing through the FB.

Detailed description: Rationale: A device called FeelBreahte (FB)® has been designed, developed and patented for inspiratory muscle training in dynamic situations.

Objetive: To examine the effects of FB on lung ventilation, gas exchange and heart rate during exercise in patients with COPD.

Methods: 20 men with COPD with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. In the first visit to the laboratory, baseline static maximum inspiratory pressure and spirometry were performed previous to the exercise. Then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. During the second day, each participant conducted two tests with 30 min of rest between them. Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing through the FB.

Results: Lung ventilation and gas exchange during exercise in COPD patients was modified during exercise using FB. Our results showed a positive effects of FB vs ONB on dynamic hyperinflation, an improved breathing pattern and breathing efficiency, higher expiratory and inspiratory time and higher perceived effort. Despite these differences, blood oxygen saturation percentage, oxygen uptake and heart rate showed similar response between both conditions.

Conclusions: The new device FB used during exercise in COPD patients influenced ventilatory responses to an efficiency breathing compared to oronasal mode.

Eligibility criteria: Inclusion Criteria:

Patients diagnosed of Chronic Obstructive Pulmonary Disease (COPD) at least 6 months before, with a forced expiratory volume in the first second (FEV1) between 70 and 30% of predicted value

Exclusion Criteria:

* Suffer other illness.
* Unwillingness to complete the study requirements.
* Cardiovascular diseases (resting electrocardiogram and during exercise).
* Elevated resting blood pressure (\>130/85 mmHg). All inclusion and exclusion criteria were assessed by a detailed medical history and, where noted, by specific measurements.

Primary outcomes:
measure: Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD
timeFrame: Subjects were assessed during 8 weeks
Secondary outcomes:
measure: Maximal 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 Fernándo
country: Spain
facility: Centro Andaluz Medicina del Deporte
state: Cádiz
Study officials:
affiliation: Hospital Puerta del Mar Cádiz Spain
name: Aurelio Arnedillo Muñoz, PhD
role: STUDY_DIRECTOR
affiliation: Centro de Medicina del Deporte. Junta de Andalucía. Cádiz
name: Carmen Vaz Pardal, MD
role: STUDY_DIRECTOR
affiliation: Universidad Autonoma de Madrid
name: Jose Lopez Chicharro, PhD
role: STUDY_DIRECTOR
affiliation: University of Cadiz
name: Pelayo Arroyo García, PhD
role: STUDY_CHAIR
affiliation: University of Cadiz
name: Jose Castro Piñero, PhD
role: STUDY_DIRECTOR
affiliation: University of Cadiz
name: Jorge dR Fernández Santos, PhD Student
role: STUDY_CHAIR
affiliation: Universidad Complutense de Madrid
name: Davinia Vicente Campos, PhD
role: STUDY_CHAIR
affiliation: University of Cadiz
name: José L. González Montesinos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cadiz
name: Julio Conde Caveda, PhD
role: STUDY_CHAIR
affiliation: University of Cadiz
name: Jesús G Ponce González, PhD
role: STUDY_DIRECTOR
References: