Feel Breathe, Restriction Device Ventilatory Nasal (COPD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exercie oronasal breathing (ONB)

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)

Group Type EXPERIMENTAL

Exercie oronasal breathing (ONB)

Intervention Type OTHER

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

Exercie nasal breathing through the FB

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

Group Type EXPERIMENTAL

Exercie nasal breathing through the FB

Intervention Type 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)

Interventions

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Exercie oronasal breathing (ONB)

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

Intervention Type OTHER

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)

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No