Quantifying Fatigue of the Respiratory and Swallowing Musculature in Patients With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in peak cough flow (PCF) between pre and post expiratory muscle strength training (EMST) experimental session
研究概览
简要总结
Expiratory muscle strength training (EMST) is an emerging palliative intervention for prolonging pulmonary and swallow function in patients with amyotrophic lateral sclerosis (PALS), but it is unknown whether EMST may result in detrimental immediate to short-term fatigue because there is no way to measure fatigue non-invasively. This study will determine the immediate to short-term impact of EMST on objective respiratory and swallow function, whether subjective ratings of dyspnea and fatigue map to objective decompensation of respiratory and swallow function, and the ability to monitor fatigue of the respiratory and swallowing musculature non-invasively. Findings from this research study will provide preliminary evidence regarding optimal timing for PALS to complete EMST and will provide PALS and clinicians increased capabilities to monitor fatigue non-invasively.
详细描述
This research proposal will determine the immediate impact of expiratory muscle strength training (EMST) on fatigue of the respiratory and swallowing musculature, whether objective decompensation translates to subjective dyspnea and fatigue, and whether high resolution cervical auscultation (HRCA) signal features can noninvasively capture and characterize physiologic decompensation that relates to fatigue in patients with amyotrophic lateral sclerosis (PALS) via three Specific Aims.
Aim 1) Determine the impact of one EMST session on objective respiratory and swallow function.
Hypothesis 1) One EMST session will result in reduced pulmonary function tests (PFTs) (maximum expiratory pressure, forced vital capacity, peak cough flow) and declines in swallow function (Videofluoroscopy (VF), HRCA). PALS will have greater reductions in PFTs, and objective declines in swallow function after the experimental condition compared to the control condition.
Aim 2) Determine if objective decompensation translates to subjective ratings of dyspnea and fatigue after one EMST session.
Hypothesis 2) Subjective ratings of dyspnea and fatigue (Situational Fatigue Scale; Dyspnea ALS-15) will be associated with objective decompensation in respiratory and swallow function (PFTs, VF, HRCA) after one EMST session.
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
- Double (Participant, Care Provider)
盲法说明
During the experimental condition, expiratory muscle strength training (EMST) devices will be set to 50% of patients with ALS' highest maximum expiratory pressure from their baseline pulmonary function test assessment. During the control condition, no resistance will be added, and the loaded spring will be removed from the device. For both experimental conditions, patients with ALS will be blinded to condition.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ALS defined as possible, probable, or definite by a neurologist using the El Escorial criteria
- •FVC>65% predicted
- •adequate cognition as defined by a score of >10 on the ALS Cognitive Behavioral Screen
- •adequate labial seal for completing pulmonary function tests and expiratory muscle strength training (EMST)
- •on a regular/thin liquid diet
- •no allergies to barium
- •not oxygen-dependent
- •no tracheostomy/ mechanical ventilation
- •no history of other neurological or respiratory disorders
- •no history of smoking
- •no history of head and neck cancer or other major head/neck surgery or radiation therapy.
排除标准
- •FVC<65% predicted
- •inadequate cognition as defined by a score of <10 on the ALS Cognitive Behavioral Screen -inadequate labial seal for completing pulmonary function tests and expiratory muscle strength training (EMST)
- •not on a regular/thin liquid diet
- •allergies to barium
- •oxygen-dependent
- •presence of tracheostomy/dependent on mechanical ventilation
- •history of other neurological or respiratory disorders
- •history of smoking
- •history of head and neck cancer or other major head/neck surgery or radiation therapy.
结局指标
主要结局
Change in peak cough flow (PCF) between pre and post expiratory muscle strength training (EMST) experimental session
时间窗: pre and post EMST experimental session, up to 2 weeks
PCF is a measure of air flow during a cough.
Change in peak cough flow (PCF) between pre and post expiratory muscle strength training (EMST) sham session
时间窗: pre and post EMST sham session, up to 2 weeks
PCF is a measure of air flow during a cough.
Change in maximum expiratory pressure (MEP) between pre and post expiratory muscle strength training (EMST) sham session
时间窗: pre and post EMST sham session, up to 2 weeks
Maximum expiratory pressure is a measure of strength of the respiratory muscles when breathing out
Change in forced vital capacity (FVC) between pre and post expiratory muscle strength training (EMST) sham session
时间窗: pre and post EMST sham session, up to 2 weeks
FVC is a measure of the total amount of air that can be breathed out during a pulmonary function test to measure lung function.
Change in maximum expiratory pressure (MEP) between pre and post expiratory muscle strength training (EMST) experimental session
时间窗: pre and post EMST experimental session, up to 2 weeks
Maximum expiratory pressure is a measure of strength of the respiratory muscles when breathing out
Change in temporal kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) experimental session
时间窗: pre and post EMST experimental session, up to 2 weeks
Timing measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in frames per second)
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores of swallowing between pre and post expiratory muscle strength training (EMST) experimental session
时间窗: pre and post EMST experimental session, up to 2 weeks
The MBSImP is a standardized clinical ordinal, categorical rating tool of 17 physiological components of swallowing
Change in spatial kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) sham session
时间窗: pre and post EMST sham session, up to 2 weeks
Distance measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in pixels)
Change in forced vital capacity (FVC) between pre and post expiratory muscle strength training (EMST) experimental session
时间窗: pre and post EMST experimental session, up to 2 weeks
FVC is a measure of the total amount of air that can be breathed out during a pulmonary function test to measure lung function.
Change in temporal kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) sham session
时间窗: pre and post EMST sham session, up to 2 weeks
Timing measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in frames per second)
Change in spatial kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) experimental session
时间窗: pre and post EMST experimental session, up to 2 weeks
Distance measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in pixels)
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores of swallowing between pre and post expiratory muscle strength training (EMST) sham session
时间窗: pre and post EMST sham session, up to 2 weeks
The MBSImP is a standardized clinical ordinal, categorical rating tool of 17 physiological components of swallowing
次要结局
- Change in high resolution cervical auscultation (HRCA) signal features between pre and post expiratory muscle strength training (EMST) experimental session(pre and post EMST experimental session, up to 2 weeks)
- Change in high resolution cervical auscultation (HRCA) signal features between pre and post expiratory muscle strength training (EMST) sham session(pre and post EMST sham session, up to 2 weeks)
研究者
Cara Donohue
MA CCC-SLP/PhD Student
University of Pittsburgh