Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® Device in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Oxygen uptake during incremental test to exhaustion on treadmill
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
FB group
Participants who performed an exercise training program for 8 weeks using a nasal restriction device for inspiratory muscle training, called Feelbreathe®
干预措施: Exercise training program with and without FB (Device)
ONB group
Participants who performed an exercise training program for 8 weeks with oronasal breathing without FB
干预措施: Exercise training program with and without FB (Device)
control group (CG)
Participants who received the standard medical recommendations for patients with COPD, but not participated in the exercise intervention program
结局指标
主要结局
Oxygen uptake during incremental test to exhaustion on treadmill
时间窗: 8 WEEKS
mL/min
Ventilation during incremental test to exhaustion on treadmill
时间窗: 8 WEEKS
L/min
次要结局
- The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD)(8 WEEKS)
- dyspnea scale(8 WEEKS)
- exercise capacity using the distance walked in the six minutes walking test (6MWT)(8 WEEKS)
研究者
Jesus Gustavo Ponce González
Principal Investigator
University of Cadiz