Pulmonary Disease, Chronic Obstructive Clinical Trial
— EPOC_2_0Official title:
Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® Device in COPD Patients
Verified date | May 2019 |
Source | University of Cadiz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Cadiz | Bahía Sur Andalusian Center for Sports Medicine, Sociedad Española de Neumología y Cirugía Torácica, University Hospital Puerta del Mar |
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
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 |
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