Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons With ALS
Nova Southeastern University
Summary
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: 1. Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS. 2. Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment. 3. Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.
Description
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 Scal…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria. 2. Disease duration from symptom onset of ≤ 2 years, 3. Lung volume recruitment and expiratory muscle strength training naïve, 4. Reduced peak cough flow (% predicted for age and gender). Exclusion Criteria: 1. History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment. 2. Use of prescription cough assist or non-invasive volume ventilation devices. 3. Enrollment in another research investigation that mig…
Interventions
- DeviceRespiratory Muscle Strength Training (LVR+EMST)
Combined respiratory muscle strength training regimen that will be completed daily for 5 weeks.
Location
- Nova Southeastern UniversityFort Lauderdale, Florida