Pulmonary Disease, Chronic ObstructiveEPOC_2_0NCT03936348
Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients
A study testing Exercise training program with and without FB in people with Pulmonary Disease, Chronic Obstructive and Breathing Exercises, run by University of Cadiz.
Trial summary
This study evaluates the effects of a nasal restriction device for inspiratory muscle training (FeelBreathe) after 8 weeks of exercise intervention on exercise capacity, quality of life, dyspnea and inspitarotory muscle strength in patients with stable COPD. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men only
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Breathing Exercises, Exercise Tolerance
- What is being tested?
- Exercise training program with and without FB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 18 Dec 2017
- 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 35 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men with diagnosis of COPD according to guidelines criteria
- with moderate or severe airflow obstruction (GOLD 2 or 3)
- dyspnea grade 2 or greater by mMRC scale
- stable clinical condition for at least 2 months.
Who cannot join
- poor compliance
- treatment with oxygen therapy or non-invasive mechanical ventilation
- CO2 retention
- medical conditions that can produce or increase dyspnea on exercise in addition to COPD (cardiovascular, metabolic or other respiratory diseases)
- osteoarticular or neuromuscular diseases that may limit the correct performance of the 6MWT
About this study
Official title: Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® Device in COPD Patients
This study evaluates the effects of a nasal restriction device for inspiratory muscle training (FeelBreathe) after 8 weeks of exercise intervention on exercise capacity, quality of life, dyspnea and inspitarotory muscle strength in patients with stable COPD. Participants were divided in three groups: 1) exercise intervention using the Feelbreathe® device (FB group), 2) exercise intervention with oronasal breathing without FB (ONB group) and 3) no participation in the exercise intervention as control group (CG).
Read the detailed description
The Feelbreathe® device, tested in the investigator's study can be used in static and dynamic situations and is a nasal ventilatory flow restriction device made by a strip of hypoallergenic material (3M Spain, S.A. Medical Specialties / O.E.M.) that is placed and adhered under the nostrils impairing the free pass of air through the nose by producing resistance to flow. Depend on the size or/and porosity of the device, the inspiratory process is more or less difficult. It can be used while performing dynamic exercise or doing daily living activities. The Feelbreathe® device (FB) has been authorized by the Spanish Agency for Medicines and Health Products for application on COPD patients (Expedient 521/15/EC. AEMPS-Madrid-Spain-Patent Nº: P200902402).
- Being tested
- Exercise training program with and without FB
- Keywords
- Pulmonary rehabilitation, Medical device, FeelBreathe, Exercise intervention, Equipment and Supplies
- 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.
Exercise training program with and without FBDevice
Also called Pulmonary rehabilitation program
Participants carried out a supervised RP for 8 weeks, 3 days per week. The training sessions lasted 60 minutes and included a warning up phase, the main phase and a recovery phase. After each session, Borg's perceived exertion was measured. The Rehabilitation Program (RP) included aerobic exercise on cycle ergometer and on treadmill (progressing since 10' to 30' and since 40 to 75% of the reserve heart rate (RHR) or 6-7 score based on Borg's perceived exertion), strengthening of lower and upper limb muscles groups, breathing exercises (pursed lip breathing, diaphragmatic and abdominal breathing and diaphragmatic mobility) and finally stretching exercises.
In the FB group, for restricted nasal breathing, at the beginning of the training program, the small size device was used (4 mm). The size of the device was progressively increasing according to the patient adaptation to the 5 or 6 mm device, depending on the score on Borg's perceived exertion scale.
| Study group | Role | What they receive |
|---|---|---|
| FB group | Experimental | Participants who performed an exercise training program for 8 weeks using a nasal restriction device for inspiratory muscle training, called Feelbreathe® Receives: Device: Exercise training program with and without FB |
| ONB group | Experimental | Participants who performed an exercise training program for 8 weeks with oronasal breathing without FB Receives: Device: Exercise training program with and without FB |
| control group (CG) | No intervention | Participants who received the standard medical recommendations for patients with COPD, but not participated in the exercise intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake during incremental test to exhaustion on treadmill
mL/min
Measured: 8 WEEKS
Ventilation during incremental test to exhaustion on treadmill
L/min
Measured: 8 WEEKS
Secondary outcomes (3)
dyspnea scale
mMRC (Modified Medical Research Council) Dyspnea Scale. Values from 0 (better) to 4 (worse) about disability attributable to breathlessness
Measured: 8 WEEKS
The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD)
The COPD Assessment Test (CAT) score measures the impact that COPD (Chronic Obstructive Pulmonary Disease) is having on the wellbeing and daily life of the patient. Score from 0 (better) to 40 (worse) about the impact of COPD symptoms on patients' overall health.
Measured: 8 WEEKS
exercise capacity using the distance walked in the six minutes walking test (6MWT)
distance measured in meters
Measured: 8 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start15 Jan 2016
- Primary completion25 Jul 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Patients were randomized to 3 groups. The first one performed a supervised RP using the Feelbreathe® device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG). The RP was conducted during 8 weeks, 3 days per week, and includes a combined training of endurance and strength exercises.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica, Hospital Universitario Puerta del Mar, Bahía Sur Andalusian Center for Sports Medicine
- Responsible party
- Principal investigator, Jesus Gustavo Ponce González, University of Cadiz
- Investigators
- Jose L González Montesinos, PhD, Principal investigator, University of Cádiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936348
- Sponsor's protocol ID
- (SEPAR): CÓDIGO: 099/2015
- Acronym
- EPOC_2_0
- Status last verified
- May 2019
- First submitted
- 28 Apr 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since there is personal and not transferable data
Publications
González-Montesinos JL, Vaz Pardal C, Fernández Santos JR, Arnedillo Muñoz A CSJ y GE de los MR. Efectos del entrenamiento de la musculatura respiratoria sobre el rendimiento. Revisión bibliográfica. Rev Andal Med Deport. 2012;5(4):163-70.
González Montesinos JL, Costa Sepúlveda JL, Fernández Santos J, Gómez Espinosa de los Monteros R, Mora Vicente J, Castro Piñero J y, et al. Dispositivo de Restricción y Filtrado del Flujo Ventilatorio Nasal. P200902402, 2011. p. 1-4.
Gonzalez-Montesinos JL, Ponce-Gonzalez JG, Vicente-Campos D, Lopez-Chicharro J, Fernandez-Santos Jdel R, Vaz-Pardal C, Costa-Sepulveda JL, Conde-Caveda J, Castro-Pinero J. Efectos de un dispositivo de restriccion ventilatoria nasal sobre la ventilacion pulmonar e intercambio gaseoso durante el ejercicio en personas sanas. Nutr Hosp. 2016 Mar 25;33(2):130. doi: 10.20960/nh.130.
PubMed 27238811Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.
PubMed 11069801Wada JT, Borges-Santos E, Porras DC, Paisani DM, Cukier A, Lunardi AC, Carvalho CR. Effects of aerobic training combined with respiratory muscle stretching on the functional exercise capacity and thoracoabdominal kinematics in patients with COPD: a randomized and controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Oct 28;11:2691-2700. doi: 10.2147/COPD.S114548. eCollection 2016.
PubMed 27822031Camillo CA, Osadnik CR, van Remoortel H, Burtin C, Janssens W, Troosters T. Effect of "add-on" interventions on exercise training in individuals with COPD: a systematic review. ERJ Open Res. 2016 Mar 29;2(1):00078-2015. doi: 10.1183/23120541.00078-2015. eCollection 2016 Jan.
PubMed 27730178
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® Device in COPD Patients
- ClinicalTrials.gov ID
- NCT03936348
- Acronym / sponsor ID
- EPOC_2_0 / (SEPAR): CÓDIGO: 099/2015
- Keywords
- Pulmonary rehabilitation, Medical device, FeelBreathe, Exercise intervention, Equipment and Supplies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica, Hospital Universitario Puerta del Mar, Bahía Sur Andalusian Center for Sports Medicine
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 3 May 2019 (actual)
- 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.
This study evaluates the effects of a nasal restriction device for inspiratory muscle training (FeelBreathe) after 8 weeks of exercise intervention on exercise capacity, quality of life, dyspnea and inspitarotory muscle strength in patients with stable COPD. Participants were divided in three groups: 1) exercise intervention using the Feelbreathe® device (FB group), 2) exercise intervention with oronasal breathing without FB (ONB group) and 3) no participation in the exercise intervention as control group (CG).
Detailed description
The Feelbreathe® device, tested in the investigator's study can be used in static and dynamic situations and is a nasal ventilatory flow restriction device made by a strip of hypoallergenic material (3M Spain, S.A. Medical Specialties / O.E.M.) that is placed and adhered under the nostrils impairing the free pass of air through the nose by producing resistance to flow. Depend on the size or/and porosity of the device, the inspiratory process is more or less difficult. It can be used while performing dynamic exercise or doing daily living activities. The Feelbreathe® device (FB) has been authorized by the Spanish Agency for Medicines and Health Products for application on COPD patients (Expedient 521/15/EC. AEMPS-Madrid-Spain-Patent Nº: P200902402).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients were randomized to 3 groups. The first one performed a supervised RP using the Feelbreathe® device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG). The RP was conducted during 8 weeks, 3 days per week, and includes a combined training of endurance and strength exercises.
| Arm | Type | Receives |
|---|---|---|
| FB group | Experimental | Device: Exercise training program with and without FBParticipants who performed an exercise training program for 8 weeks using a nasal restriction device for inspiratory muscle training, called Feelbreathe® |
| ONB group | Experimental | Device: Exercise training program with and without FBParticipants who performed an exercise training program for 8 weeks with oronasal breathing without FB |
| control group (CG) | No intervention | –Participants who received the standard medical recommendations for patients with COPD, but not participated in the exercise intervention program |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men with diagnosis of COPD according to guidelines criteria
- with moderate or severe airflow obstruction (GOLD 2 or 3)
- dyspnea grade 2 or greater by mMRC scale
- stable clinical condition for at least 2 months.
Key exclusion criteria (5 listed)
- poor compliance
- treatment with oxygen therapy or non-invasive mechanical ventilation
- CO2 retention
- medical conditions that can produce or increase dyspnea on exercise in addition to COPD (cardiovascular, metabolic or other respiratory diseases)
- osteoarticular or neuromuscular diseases that may limit the correct performance of the 6MWT
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 |
|---|---|---|
| Exercise training program with and without FBAlso: Pulmonary rehabilitation programParticipants carried out a supervised RP for 8 weeks, 3 days per week. The training sessions lasted 60 minutes and included a warning up phase, the main phase and a recovery phase. After each session, Borg's perceived exertion was measured. The Rehabilitation Program (RP) included aerobic exercise on cycle ergometer and on treadmill (progressing since 10' to 30' and since 40 to 75% of the reserve heart rate (RHR) or 6-7 score based on Borg's perceived exertion), strengthening of lower and upper limb muscles groups, breathing exercises (pursed lip breathing, diaphragmatic and abdominal breathing and diaphragmatic mobility) and finally stretching exercises. In the FB group, for restricted nasal breathing, at the beginning of the training program, the small size device was used (4 mm). The size of the device was progressively increasing according to the patient adaptation to the 5 or 6 mm device, depending on the score on Borg's perceived exertion scale. | Device | FB group, ONB group |
Primary outcome
Oxygen uptake during incremental test to exhaustion on treadmill
Time frame: 8 WEEKS
mL/min
Ventilation during incremental test to exhaustion on treadmill
Time frame: 8 WEEKS
L/min
3 secondary outcomes
dyspnea scale
Time frame: 8 WEEKS
The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD)
Time frame: 8 WEEKS
exercise capacity using the distance walked in the six minutes walking test (6MWT)
Time frame: 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 31 May 2019.
- BackgroundGonzález-Montesinos JL, Vaz Pardal C, Fernández Santos JR, Arnedillo Muñoz A CSJ y GE de los MR. Efectos del entrenamiento de la musculatura respiratoria sobre el rendimiento. Revisión bibliográfica. Rev Andal Med Deport. 2012;5(4):163-70.
- Results publicationGonzález Montesinos JL, Costa Sepúlveda JL, Fernández Santos J, Gómez Espinosa de los Monteros R, Mora Vicente J, Castro Piñero J y, et al. Dispositivo de Restricción y Filtrado del Flujo Ventilatorio Nasal. P200902402, 2011. p. 1-4.
- Results publication: PubMed 27238811Gonzalez-Montesinos JL, Ponce-Gonzalez JG, Vicente-Campos D, Lopez-Chicharro J, Fernandez-Santos Jdel R, Vaz-Pardal C, Costa-Sepulveda JL, Conde-Caveda J, Castro-Pinero J. Efectos de un dispositivo de restriccion ventilatoria nasal sobre la ventilacion pulmonar e intercambio gaseoso durante el ejercicio en personas sanas. Nutr Hosp. 2016 Mar 25;33(2):130. doi: 10.20960/nh.130.
- Results publication: PubMed 11069801Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.
- Results publication: PubMed 27822031Wada JT, Borges-Santos E, Porras DC, Paisani DM, Cukier A, Lunardi AC, Carvalho CR. Effects of aerobic training combined with respiratory muscle stretching on the functional exercise capacity and thoracoabdominal kinematics in patients with COPD: a randomized and controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Oct 28;11:2691-2700. doi: 10.2147/COPD.S114548. eCollection 2016.
- Results publication: PubMed 27730178Camillo CA, Osadnik CR, van Remoortel H, Burtin C, Janssens W, Troosters T. Effect of "add-on" interventions on exercise training in individuals with COPD: a systematic review. ERJ Open Res. 2016 Mar 29;2(1):00078-2015. doi: 10.1183/23120541.00078-2015. eCollection 2016 Jan.
- Individual participant dataSharing planned: No. Since there is personal and not transferable data
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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.
Jose L González Montesinos, PhD principal investigator
University of Cádiz
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training program with and without FB in people with Pulmonary Disease, Chronic Obstructive and Breathing Exercises, run by University of Cadiz.
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 4 inclusion and 5 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 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Oxygen uptake during incremental test to exhaustion on treadmill (time frame: 8 WEEKS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936348, which also lists 6 linked publications.
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 31 May 2019.