Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
Amyotrophic Lateral Sclerosis
About this trial
This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 < 0.7.
- 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
Sites / Locations
- University of Florida
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Expiratory Muscle Strength Testing (EMST)
EMST + Lung Volume Recruitment (LVR)
EMST is a treatment method that has been used to improve cough function and swallowing in ALS. EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week.
EMST is a treatment method that has been used to improve cough function and swallowing in ALS. EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week. LVR is a technique to increase cough function that is performed with a resuscitation bag fitted with a mouthpiece and a one-way valve. The bag is used to expand the lungs, after which the patient makes a voluntary cough.