INNOTORIO: Innovations in the Training of the Inspiratory Muscles on Patients With Chronic Obstructive Pulmonary Disease: Design of a Digital Dual Valve and Evaluation of a New High-intensity Training Scheme of Short Duration.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Respiratory muscle strength assessed by Maximun Respiratory Pressure
研究概览
简要总结
Respiratory muscle weakness and fatigue are related to clinical deterioration in patients with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a key therapeutic strategy in these patients. It is necessary therefore to increase its dissemination on a large scale, improve patient´s adherence and optimize the control of the implementation of training. The aim of this project was to design a RMT device including light and sound incentives, digital registration application and analysis of the training sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity that could provide added value to enhance the implementation of training in patients with COPD. From an operational point of view, researches were organized into three packages of complementary work focused on the design of a new portable dual valve with electronic lighting and auditory incentives components. The conceptualization and design of a software to analyze the performance and individual continuous use of the valve, and the evaluation of the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training in adult patients with COPD were realized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis from moderate to severe COPD muscle weakness inspiratory Must be able to do exercises
排除标准
- •Positive bronchodilator response Cardiovascular, neuromuscular, or metabolic disease Hospital admission for any pathology in the last two months have completed a rehabilitation program in the last year
结局指标
主要结局
Change in Respiratory muscle strength assessed by Maximun Respiratory Pressure
时间窗: From baseline to 3 weeks
Defined as the ability to make a maximum respiratory effort, it was assessed using the MicroRPM® device. This test is to generate the maximum inspiratory pressure (from residual volume) and expiratory (from total lung capacity) against a road or occluded team, performing the maneuver by keeping the mouth and nose occluded.
Change in Exercise Capacity assessed by cardiopulmonary exercise testing
时间窗: From baseline to 3 weeks
Change in Quality of life assessed by Quality of life Short Form 36 questionnaire
时间窗: From baseline to 3 weeks
次要结局
- Change in Exercise Capacity assessed by Six minutes walking Test(From baseline to 3 weeks)
- Change in Respiratory function assessed by spirometry(From baseline to 3 weeks)