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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— EPOC_2_0  

Official title:

Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® Device in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936348
• Other study ID #: (SEPAR): CÓDIGO: 099/2015
• Status: Completed
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: December 18, 2017

Study information

• Verified date: May 2019
• Source: University of Cadiz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 18, 2017
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breathing Exercises
• Chronic Disease
• Exercise Tolerance
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Cadiz	Bahía Sur Andalusian Center for Sports Medicine, Sociedad Española de Neumología y Cirugía Torácica, University Hospital Puerta del Mar

References & Publications (6)

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). pii: 00078-2015. eCollection 2016 Jan. Review. — View 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.

González-Montesinos JL, Ponce-González JG, Vicente-Campos D, López-Chicharro J, Fernández-Santos Jdel R, Vaz-Pardal C, Costa-Sepúlveda JL, Conde-Caveda J, Castro-Piñero J. [Not Available]. Nutr Hosp. 2016 Mar 25;33(2):130. doi: 10.20960/nh.130. — View 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.

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. — View 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 random — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen uptake during incremental test to exhaustion on treadmill	mL/min	8 WEEKS
Primary	Ventilation during incremental test to exhaustion on treadmill	L/min	8 WEEKS
Secondary	dyspnea scale	mMRC (Modified Medical Research Council) Dyspnea Scale. Values from 0 (better) to 4 (worse) about disability attributable to breathlessness	8 WEEKS
Secondary	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
Secondary	exercise capacity using the distance walked in the six minutes walking test (6MWT)	distance measured in meters	8 WEEKS