Amyotrophic Lateral Sclerosis
Conditions
Brief summary
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.
Interventions
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.
PROCEDUREEMST + Lung Volume Recruitment (LVR)
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. Half of the participants will perform the LVR technique in addition to the ESMT technique.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Cough Flow | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility Test (SIT) | Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12) | Standardized assessment of speech intelligibility and efficiency in neuromuscular disorders. Measures changes in speech intelligibility at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12). |
| Maximal Expiratory Pressure | Week 0, Week 6, Week 8, Week 10, and Week 12 | Measurement of respiratory muscle strength changes at Baseline (Week 0), Randomization (Week 6), Week 8, Week 10, and End of Study (Week 12) |
| Forced Vital Capacity | Baseline (Week 0), Week 6, and Week 12 | Measurement of changes in how much air is exhaled over a series of forced breaths at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12) |
| Eating Assessment Tool - 10 (EAT-10) | Baseline (Week 0), Week 6, and Week 12 | 10-item patient reported outcome assessing changes in swallowing function at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12) |
| Swallowing Related Quality of Life (SWAL-QOL) | Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12) | 44-item patient reported outcome assessing changes in swallowing impairment at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12) |
Countries
United States
Outcome results
None listed