Feel Breathe, Restriction Device Ventilatory Nasal (COPD) (BreatheCOPD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fondo Europeo de Desarrollo Regional
Information provided by (Responsible Party):
Jose Luis Gonzalez Montesinos, University of Cadiz
ClinicalTrials.gov Identifier:
NCT01695265
First received: September 24, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Device: Feel Breathe, restriction device ventilatory nasal in COPD

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Feel Breathe, Restriction Device Ventilatory Nasal (COPD)

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 COPD [ Time Frame: Subjects were assessed during 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Maximal Oxygen uptake [ Time Frame: Subjects were assessed during 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ 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%. 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.


Estimated Enrollment: 15
Study Start Date: February 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01695265

Locations
Spain
Centro Andaluz Medicina del Deporte
San Fernándo, Cádiz, Spain, 11100
Sponsors and Collaborators
University of Cadiz
Fondo Europeo de Desarrollo Regional
Investigators
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 Autónoma de Madrid
Study Chair: Pelayo Arroyo García, PhD Universidad de Cádiz
Study Director: Jose Castro Piñero, PhD Universidad de Cádiz
Study Chair: Jorge dR Fernández Santos, PhD Student Universidad de Cádiz
Study Chair: Davinia Vicente Campos, PhD Universidad Complutense de Madrid
Principal Investigator: José L. González Montesinos, PhD Universidad de Cádiz
Study Director: Julio Conde Caveda, PhD Universidad de Cádiz
  More Information

No publications provided

Responsible Party: Jose Luis Gonzalez Montesinos, Principal Investigator, University of Cadiz
ClinicalTrials.gov Identifier: NCT01695265     History of Changes
Other Study ID Numbers: AC26392COPD
Study First Received: September 24, 2012
Last Updated: May 15, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by University of Cadiz:
Airflow Obstruction

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014