Fundamentation of TEDS Protocol in Healthy Subjects and Its Application in COPD Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Respiratory muscle strength and spirometry
研究概览
简要总结
Transcutaneous electrical diaphragmatic stimulation (TEDS) has been used to improve respiratory muscle strength in patients with respiratory muscles weakness. However, this physiotherapeutic resource has not been studied in chronic obstructive pulmonary disease (COPD) yet. The objective of this study is to evaluate the respiratory pattern during the session of TEDS besides its effect in respiratory muscle strength and in spirometric variables as much healthy patients as in COPD patients. Methods: healthy and COPD patients are selected and submitted to TEDS treatment. The plethysmographic analysis (LifeShirt System - VivoMetric), respiratory muscle strength and spirometry will be made. The hypothesis is that the TEDS can helps COPD patients that shows respiratory muscle weakness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with stable COPD (diagnosed by accepted criteria)
- •Healthy patients
排除标准
- •FOR THE COPD PATIENTS:
- •Over 80 years of age
- •History of recent exacerbation
- •Patients with pacemakers
- •Uncontrolled arterial hypertension
- •Requiring home oxygen therapy.
- •FOR THE HEALTHY PATIENTS:
- •Pulmonary diseases
- •Cardiovascular diseases
- •Orthopedic diseases
- •Neurologic diseases.
结局指标
主要结局
Respiratory muscle strength and spirometry
时间窗: 06 weeks
Respiratory muscle strength: maximal inspiratory pressure (cH2O) and maximal expiratory pressure (cH2O) by manovacuometer (Gerar®) Spirometry by Spirometer EasyOne®
次要结局
- Respiratory pattern(During the session of transcutaneous electrical diaphragmatic stimulation)