Clinical trial NCT03936348: Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients
Official title: Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® Device in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Breathing Exercises
Exercise Tolerance
Keywords: Pulmonary rehabilitation
Medical device
FeelBreathe
Exercise intervention
Equipment and Supplies
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
name: Hospital Universitario Puerta del Mar
name: Bahía Sur Andalusian Center for Sports Medicine
First posted: 2019-05-03
Enrollment: 16
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oxygen uptake during incremental test to exhaustion on treadmill
timeFrame: 8 WEEKS
measure: Ventilation during incremental test to exhaustion on treadmill
timeFrame: 8 WEEKS
Secondary outcomes:
measure: dyspnea scale
timeFrame: 8 WEEKS
measure: The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD)
timeFrame: 8 WEEKS
measure: exercise capacity using the distance walked in the six minutes walking test (6MWT)
timeFrame: 8 WEEKS
Other outcomes:
Locations:
Study officials:
affiliation: University of Cádiz
name: Jose L González Montesinos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Scherer 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.
citation: Wada 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.
citation: Camillo 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.