Feel Breathe, Restriction Device Ventilatory Nasal (COPD)

NCT01695265 | Completed

• 1 other identifier: AC26392COPD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Airflow Obstruction

Outcome Measures

Primary Outcomes (1)

• Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD

  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 50% of VO2peak 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.

  Subjects were assessed during 8 weeks

Secondary Outcomes (2)

• Maximal Oxygen uptake

  Subjects were assessed during 8 weeks

• Maximum static inspiratory pressure (PImax)

  Subjects were assessed during 8 weeks

Study Arms (2)

Exercie oronasal breathing (ONB)

EXPERIMENTAL

Exercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with oronasal breathing (ONB) (Without FeelBreathe device)

Other: Exercie oronasal breathing (ONB)

Exercie nasal breathing through the FB

EXPERIMENTAL

Exercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with nasal restriction using FeelBreathe device.

Device: Exercie nasal breathing through the FB

Interventions

Exercie oronasal breathing (ONB) OTHER

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

Exercie oronasal breathing (ONB)

Exercie nasal breathing through the FB DEVICE

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)

Exercie nasal breathing through the FB

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Suffer other illness.
• Unwillingness to complete the study requirements.
• Cardiovascular diseases (resting electrocardiogram and during exercise).

Sponsors & Collaborators

• University of Cadiz: lead
• European Regional Development Fund: collaborator

Study Sites (1)

Centro Andaluz Medicina del Deporte

San Fernándo, Cádiz, 11100, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 DIRECTOR

• Pelayo Arroyo García, PhD

  University of Cadiz

  STUDY CHAIR

• Jose Castro Piñero, PhD

  University of Cadiz

  STUDY DIRECTOR

• Jorge dR Fernández Santos, PhD Student

  University of Cadiz

  STUDY CHAIR

• Davinia Vicente Campos, PhD

  Universidad Complutense de Madrid

  STUDY CHAIR

• José L. González Montesinos, PhD

  University of Cadiz

  PRINCIPAL INVESTIGATOR

• Julio Conde Caveda, PhD

  University of Cadiz

  STUDY CHAIR

• Jesús G Ponce González, PhD

  University of Cadiz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2015
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)