Feel Breathe, Restriction Device Ventilatory Nasal (COPD)

NCT01695265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-06-04

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Exercie oronasal breathing (ONB)

10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using oronasal breathing (ONB)

DEVICE

Exercie nasal breathing through the FB

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. 10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using FeelBreathe device (FB)

Sponsors & Collaborators

  • European Regional Development Fund

    collaborator OTHER
  • University of Cadiz

    lead OTHER

Principal Investigators

  • Aurelio Arnedillo Muñoz, PhD · Hospital Puerta del Mar Cádiz Spain

  • Carmen Vaz Pardal, MD · Centro de Medicina del Deporte. Junta de Andalucía. Cádiz

  • Jose Lopez Chicharro, PhD · Universidad Autonoma de Madrid

  • Pelayo Arroyo García, PhD · University of Cadiz

  • Jose Castro Piñero, PhD · University of Cadiz

  • Jorge dR Fernández Santos, PhD Student · University of Cadiz

  • Davinia Vicente Campos, PhD · Universidad Complutense de Madrid

  • José L. González Montesinos, PhD · University of Cadiz

  • Julio Conde Caveda, PhD · University of Cadiz

  • Jesús G Ponce González, PhD · University of Cadiz

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-06-30
Completion
2015-09-30

Countries

  • Spain

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01695265 on ClinicalTrials.gov