Completed

BreatheCOPDFeel Breathe, Restriction Device Ventilatory Nasal (COPD)

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What is being tested

Exercie oronasal breathing (ONB)

+ Exercie nasal breathing through the FB

OtherDevice
Who is being recruted

Chronic Disease+5

+ Lung Diseases

+ Lung Diseases, Obstructive

From 40 to 70 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorUniversity of Cadiz
Last updated: June 4, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Cadiz
Last updated: June 4, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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)

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Centro Andaluz Medicina del Deporte

San Fernándo, SpainOpen Centro Andaluz Medicina del Deporte in Google Maps
CompletedOne Study Center