Feel Breathe, Restriction Device Ventilatory Nasal (COPD) (BreatheCOPD)
|ClinicalTrials.gov Identifier: NCT01695265|
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : October 26, 2016
Using the FEELBREATHE®, a nasal ventilatory restriction device, during an exercise test in treadmill, produce physiological changes in patients with Chronic Obstructive Pulmonary Disease (COPD).
These changes may improve strength and endurance of the inspiratory muscles and improve exercise tolerance in these patients.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: Feel Breathe, restriction device ventilatory nasal in COPD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Feel Breathe, Restriction Device Ventilatory Nasal (COPD)|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||September 2015|
Experimental: COPD Study
15 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. Subjects who provide informed consent and meet all of the inclusion criteria and none of the exclusion criteria will be randomized.
The investigators excluded patients who have had an exacerbation in the two months prior to inclusion, patients with concomitant diseases that may cause or contribute to dyspnea on exertion (cardiovascular, metabolic or other respiratory diseases associated) or diseases that could interfere the performance of the exercise test (basically neuromuscular and skeletal diseases).
Device: Feel Breathe, restriction device ventilatory nasal in COPD
Device: Feel Breathe, restriction device ventilatory nasal The Feel Breathe (FB) consisted of a small adhesive strip that is place across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacture'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 subjet was required to perform three identical submaximal exercises with intensity at 65% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET
- Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD [ Time Frame: Subjects were assessed during 8 weeks ]The investigators measure minute ventilation, peak oxygen uptake (VO2p), peak carbon dioxide production (VCO2p), breathing frequency (BF), ventilatory equivalent for carbon dioxide (CO2 Eq), ventilatory equivalent for oxygen (Eq O2), expiratory tidal volume (Vtexp), inspiratory tidal volume (Vtins), end-tidal carbon dioxide tension (PETCO2), end-tidal oxygen tension (PETO2), inspiratory time (T.in), ratio of inspiratory duration to total breath duration (ti/t), expiratory time (Tex), oxygen saturation measure by pulse-oximetry SpO2), heart rate (HR), duration of the test and dyspnea and leg fatigue measures by Borg scale. Each subject performed two identical submaximal exercises at 65% of ventilatory threshold under different breathing conditions: 1) nasal breathing with FB and 2) oronasal breathing without FB. Incremental exercise tests were performed on a treadmill ergometer using a one minute step protocol to a symptom-limited maximum.
- Maximal Oxygen uptake [ Time Frame: Subjects were assessed during 8 weeks ]Before experimental trials each subject performed an incremental protocol on a treadmill ergometer (MONARK, Hamburg, Germany) 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 an Oxycon cardiopulmonary exercise system (Jaeger, Hoechberg, Germany).
- Maximum static inspiratory pressure (PImax) [ Time Frame: 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%. PImax was measured at residual volume and the best result from three inspiratory attempts was taken. Al least one minute was allowed between attempts to minimize the effects of muscle fatigue.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695265
|Centro Andaluz Medicina del Deporte|
|San Fernándo, Cádiz, Spain, 11100|
|Study Director:||Aurelio Arnedillo Muñoz, PhD||Hospital Puerta del Mar Cádiz Spain|
|Study Director:||Carmen Vaz Pardal, MD||Centro de Medicina del Deporte. Junta de Andalucía. Cádiz|
|Study Director:||Jose Lopez Chicharro, PhD||Universidad Autonoma de Madrid|
|Study Chair:||Pelayo Arroyo García, PhD||University of Cadiz|
|Study Director:||Jose Castro Piñero, PhD||University of Cadiz|
|Study Chair:||Jorge dR Fernández Santos, PhD Student||University of Cadiz|
|Study Chair:||Davinia Vicente Campos, PhD||Universidad Complutense de Madrid|
|Principal Investigator:||José L. González Montesinos, PhD||University of Cadiz|
|Study Director:||Julio Conde Caveda, PhD||University of Cadiz|