Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients (EPOC_2_0)

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; Exercise Tolerance; Breathing Exercises
• Intervention / Treatment: Device: Exercise training program with and without FB

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FB group; Participants who performed an exercise training program for 8 weeks using a nasal restriction device for inspiratory muscle training, called Feelbreathe®	Device: Exercise training program with and without FB; 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.; Other Names: Pulmonary rehabilitation program
Experimental: ONB group; Participants who performed an exercise training program for 8 weeks with oronasal breathing without FB	Device: Exercise training program with and without FB; 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.; Other Names: Pulmonary rehabilitation program
No Intervention: control group (CG); Participants who received the standard medical recommendations for patients with COPD, but not participated in the exercise intervention program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen uptake during incremental test to exhaustion on treadmill	mL/min	8 WEEKS
Ventilation during incremental test to exhaustion on treadmill	L/min	8 WEEKS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dyspnea scale	mMRC (Modified Medical Research Council) Dyspnea Scale. Values from 0 (better) to 4 (worse) about disability attributable to breathlessness	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.	8 WEEKS
exercise capacity using the distance walked in the six minutes walking test (6MWT)	distance measured in meters	8 WEEKS

Collaborators and Investigators

• Sponsor: University of Cadiz
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica; Hospital Universitario Puerta del Mar; Bahía Sur Andalusian Center for Sports Medicine
• Investigators: Principal Investigator: Jose L González Montesinos, PhD, University of Cadiz

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Actual): July 25, 2017
• Study Completion (Actual): December 18, 2017

Study Registration Dates

• First Submitted: April 28, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Pulmonary rehabilitation; Medical device; Exercise intervention; Equipment and Supplies; FeelBreathe
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
• Other Study ID Numbers: (SEPAR): CÓDIGO: 099/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since there is personal and not transferable data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No