Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis : Impact and Prognosis. Single-center Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Endurance time
研究概览
简要总结
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory muscles and can lead at short term to respiratory failure. The occurrence of respiratory failure is associated with morbidity and an increased mortality. To date, respiratory muscle weakness is predicted from the reduction of vital capacity, maximal inspiratory force, nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these indices is low.
The investigators hypothesize that an endurance test of diaphragmatic work would be more sensitive to respiratory muscle involvement than maximal respiratory force.
Consequently, the investigators assessed diaphragmatic performance through an isocapnic hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the occurrence of respiratory failure. The investigators make the hypothesis that IHT will be altered earlier than maximal inspiratory force
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Endurance time
时间窗: Day 1
Difference in endurance time during the IHT between healthy controls and ALS patients when diagnosis is established
次要结局
- Reference values of the diaphragmatic endurance test(Day 1)
- Latency of phrenic nerve(At Day 1 and every 3 months of follow-up (3 years))
- Slope of endurance time decrease(At Day 1 and every 3 months of follow-up (3 years))
- Reference values of phrenic nerve activity(Day 1)
- Amplitude of phrenic nerve(At Day 1 and every 3 months of follow-up (3 years))