Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients
- Conditions
- Exercise TolerancePulmonary Disease, Chronic ObstructiveBreathing Exercises
- Interventions
- Device: Exercise training program with and without FB
- Registration Number
- NCT03936348
- Lead Sponsor
- University of Cadiz
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description FB group Exercise training program with and without FB Participants who performed an exercise training program for 8 weeks using a nasal restriction device for inspiratory muscle training, called Feelbreathe® ONB group Exercise training program with and without FB Participants who performed an exercise training program for 8 weeks with oronasal breathing without FB
- Primary Outcome Measures
Name Time Method Oxygen uptake during incremental test to exhaustion on treadmill 8 WEEKS mL/min
Ventilation during incremental test to exhaustion on treadmill 8 WEEKS L/min
- Secondary Outcome Measures
Name Time Method The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD) 8 WEEKS 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.
dyspnea scale 8 WEEKS mMRC (Modified Medical Research Council) Dyspnea Scale. Values from 0 (better) to 4 (worse) about disability attributable to breathlessness
exercise capacity using the distance walked in the six minutes walking test (6MWT) 8 WEEKS distance measured in meters