NCT03202017已完成不适用
A Pilot Study of Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Peak Cough Flow
研究概览
简要总结
The purpose of this study is to investigate the effects of two treatment techniques called Expiratory Muscle Strength Training (EMST) and Lung Volume Recruitment (LVR) on breathing, swallowing, speech, and cough function in persons with mild to moderate ALS. Half of the participants will do EMST alone, and the other half of the participants will do EMST and LVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •ALS defined as possible, laboratory-supported probable, probable, or definite by El Escorial criteria
- •Reduced Maximal Expiratory Pressure (MEP) compared to norms for age and sex
- •Forced Vital Capacity (FVC) > 65% predicted
排除标准
- •Inability to provide informed consent
- •Relative contraindications to LVR, including known pneumothorax, active internal bleeding, unstable hypertension, unstable angina, emphysema, recent barotrauma, or FEV1 (Forced Expiratory Volume, trial 1)/FVC ratio < 0.
- •Use of EMST or breath stacking > 3 days/week within 12 weeks of screening
- •Amyotrophic Lateral Sclerosis-Cognitive Behavioral Scale (ALS-CBS) score predictive of dementia (≤ 10)
- •Participation in another clinical trial of an intervention in ALS within 30 days of study enrollment or during study enrollment
结局指标
主要结局
Peak Cough Flow
时间窗: Baseline (Week 0), Week 6, and Week 12
Ventilatory measure that assesses the change in coughing ability at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
次要结局
- Maximal Expiratory Pressure(Week 0, Week 6, Week 8, Week 10, and Week 12)
- Forced Vital Capacity(Baseline (Week 0), Week 6, and Week 12)
- Eating Assessment Tool - 10 (EAT-10)(Baseline (Week 0), Week 6, and Week 12)
- Swallowing Related Quality of Life (SWAL-QOL)(Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12))
- Speech Intelligibility Test (SIT)(Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12))
研究者
研究点 (4)
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