Non-invasive Ventilation and Physical Activity in Patients With Neuromuscular Disorders and Thoracic Wall Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Average daily walking time
研究概览
简要总结
As fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation in patients with neuromuscular disorders and thoracic deformations, we hope, by starting non-invasive ventilation and improving these symptoms, to increase their physical activity.
详细描述
Patients with neuromuscular disorders and thoracic deformations develop alveolar hypoventilation during their disease progression. At that time, non-invasive ventilation(NIV) can be started as treatment.
Fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation. NIV has the intention to improve these symptoms but no research has been performed whether these improvements also objectively improve physical activity. Further on, no research has been performed on muscle strength and muscle fatigue.
Patients' physical activity, physical capacity and sleep quality will be measured before NIV initiation, after 3 months and 1 year of NIV use.
To start NIV, patients will be admitted to our sleep laboratory for 5 days/4 nights. Polysomnography will be used during NIV titration.
Physical activity will each time be measured by 2 activity monitors during 5 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •restrictive pulmonary function test AND
- •symptoms of nocturnal alveolar hypoventilation or
- •increased daytime pressure of arterial CO2 (PaCO2) (>45 mmHg) or
- •>= 10 mmHg increase in PaCO2 during sleep in comparison to a normal awake supine value
排除标准
- •patients < 16 years
- •severe cardiac arrythmias or conduction disturbances
- •severe mental disturbances
- •amyotrophic lateral sclerosis
- •total wheelchair-dependent patients
结局指标
主要结局
Average daily walking time
时间窗: Measured after 1 year of NIV
Average daily walking time will be measured by the McRoberts physical activity monitor
次要结局
- Change in functional exercise capacity(After 1 year NIV use)
- Change in quadriceps fatiguability(After 1 year NIV use)
- Change in sleep structure and quality of sleep(After 1 year NIV use)
- Change in muscle strength(After 1 year NIV use)
研究者
Dr. Dries Testelmans
MD, PhD
Universitaire Ziekenhuizen KU Leuven