Chronic Obstructive Pulmonary DiseaseBreatheCOPDNCT01695265
Feel Breathe, Restriction Device Ventilatory Nasal (COPD)
A study testing Exercie oronasal breathing (ONB) and Exercie nasal breathing through the FB in people with Chronic Obstructive Pulmonary Disease, run by University of Cadiz at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Exercie oronasal breathing (ONB) and Exercie nasal breathing through the FB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Chronic Obstructive Pulmonary Disease
- Being tested
- Exercie oronasal breathing (ONB), Exercie nasal breathing through the FB
- Keywords
- Airflow Obstruction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 nasal breathing through the FBDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Device: Exercie nasal breathing through the FB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects were assessed during 8 weeks
Secondary outcomes (2)
Maximal Oxygen uptake
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).
Measured: Subjects were assessed during 8 weeks
Maximum static inspiratory pressure (PImax)
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.
Measured: Subjects were assessed during 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund
- Responsible party
- Principal investigator, Jose Luis Gonzalez Montesinos, University of Cadiz
- Investigators
- Aurelio Arnedillo Muñoz, PhD, Study director, Hospital Puerta del Mar Cádiz SpainCarmen Vaz Pardal, MD, Study director, Centro de Medicina del Deporte. Junta de Andalucía. CádizJose Lopez Chicharro, PhD, Study director, Universidad Autonoma de MadridPelayo Arroyo García, PhD, Study chair, University of CadizJose Castro Piñero, PhD, Study director, University of CadizJorge dR Fernández Santos, PhD Student, Study chair, University of CadizDavinia Vicente Campos, PhD, Study chair, Universidad Complutense de MadridJosé L. González Montesinos, PhD, Principal investigator, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695265
- Sponsor's protocol ID
- AC26392COPD
- Acronym
- BreatheCOPD
- Status last verified
- May 2018
- First submitted
- 24 Sep 2012
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All researchers included in this study could access to the database
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feel Breathe, Restriction Device Ventilatory Nasal (COPD)
- ClinicalTrials.gov ID
- NCT01695265
- Acronym / sponsor ID
- BreatheCOPD / AC26392COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Airflow Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- European Regional Development Fund
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercie oronasal breathing (ONB) | Experimental | Other: 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) |
| Exercie nasal breathing through the FB | Experimental | Device: Exercie nasal breathing through the FBExercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with nasal restriction using FeelBreathe device. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercie oronasal breathing (ONB)10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using oronasal breathing (ONB) | Other | Exercie oronasal breathing (ONB) |
| Exercie nasal breathing through the FBDevice: 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) | Device | Exercie nasal breathing through the FB |
Primary outcome
Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD
Time frame: Subjects were assessed during 8 weeks
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.
2 secondary outcomes
Maximal Oxygen uptake
Time frame: Subjects were assessed during 8 weeks
Maximum static inspiratory pressure (PImax)
Time frame: Subjects were assessed during 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Individual participant dataSharing planned: No. All researchers included in this study could access to the database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelio Arnedillo Muñoz, PhD study director
Hospital Puerta del Mar Cádiz Spain
Carmen Vaz Pardal, MD study director
Centro de Medicina del Deporte. Junta de Andalucía. Cádiz
Jose Lopez Chicharro, PhD study director
Universidad Autonoma de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercie oronasal breathing (ONB) and Exercie nasal breathing through the FB in people with Chronic Obstructive Pulmonary Disease, run by University of Cadiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD (time frame: Subjects were assessed during 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.