Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons With ALS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Peak Cough Flow
研究概览
简要总结
The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed:
- Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS.
- Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment.
- Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.
详细描述
In this delayed start, repeated-measures design, pALS will serve as their own control to provide treatment to all participants and control for disease heterogeneity (i.e., interparticipant differences). Participation will include three in-person evaluations and four weekly telehealth therapy sessions (Figure 3). Weekly telehealth therapy sessions will include home peak cough flow assessment, LVR and EMST training sessions to ensure treatment fidelity, maximum phonation time as a surrogate measure of forced vital capacity, and patient-reported outcomes including the ALS Respiratory Symptom Scale. To assess peak cough flow at home, participants will be provided with a commercially available peak cough flow meter (MiniWright, PF100) for guided assessment during telehealth appointments.
Study Timeline.
Study assessments and procedures at each time point are briefly described below and depicted in Table 1.
Screening/Baseline 1 (Week -5).
Following consenting and screening procedures, study personnel will complete the initial baseline assessment procedures. Participants will complete the initial baseline assessment in approximately 60-90 minutes.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria.
- •Disease duration from symptom onset of ≤ 2 years,
- •Lung volume recruitment and expiratory muscle strength training naïve,
- •Reduced peak cough flow (% predicted for age and gender).
排除标准
- •History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment.
- •Use of prescription cough assist or non-invasive volume ventilation devices.
- •Enrollment in another research investigation that might impact cough or respiratory function.
- •Diagnosis of frontotemporal dementia or advanced cognitive impairment.
- •Tracheostomy placement/Use of invasive mechanical ventilation.
- •Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease).
研究组 & 干预措施
Lung Volume Recruitment +Expiratory Muscle Strength Training
All enrolled participants will commence a combined lung volume recruitment and expiratory muscle strength training exercise regimen following a 5-week no-intervention lead-in period.
干预措施: Respiratory Muscle Strength Training (LVR+EMST) (Device)
结局指标
主要结局
Peak Cough Flow
时间窗: From Baseline 1 to Final Evaluation (10 weeks)
Greatest cough measurement measured in liters/minute.
次要结局
- Pulmonary Function Assessment(From Baseline 1 to Final evaluation (10 weeks))
- Cough Spirometry(From Baseline 2 to Final Evaluation (5 weeks))
- Pulmonary Function Assessment(From Baseline 1 to Final Evaluation (10 weeks))
研究者
Lauren Tabor Gray, PhD
Principal Investigator
Nova Southeastern University