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

University of Cadiz

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive; Exercise Tolerance; Breathing Exercises

Treatments: Device: Exercise training program with and without FB

Study type: Interventional

Funder types: Other

Identifiers

NCT03936348

(SEPAR): CÓDIGO: 099/2015

Details and patient eligibility

About

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).

Full 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).

Enrollment: 16 patients

Sex: Male

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

FB group

Experimental group

Description:

Participants who performed an exercise training program for 8 weeks using a nasal restriction device for inspiratory muscle training, called Feelbreathe®

Treatment:

Device: Exercise training program with and without FB

ONB group

Experimental group

Description:

Participants who performed an exercise training program for 8 weeks with oronasal breathing without FB

Treatment:

Device: Exercise training program with and without FB

control group (CG)

No Intervention group

Description:

Participants who received the standard medical recommendations for patients with COPD, but not participated in the exercise intervention program