Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons With ALS

What this Trial Is About

Researchers are evaluating the effects of combined lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in people diagnosed with amyotrophic lateral sclerosis (ALS). This study aims to understand how these combined exercises impact cough strength, respiratory function, patient-reported breathing difficulty, bulbar impairment, and the quality of life reported by patients and their caregivers. The study is interventional and includes up to 39 participants with ALS, focusing on the respiratory challenges associated with the disease. Participants will first undergo a 5-week no-treatment lead-in period serving as their own control to manage disease differences. Following this, all participants will receive the combined LVR and EMST exercise regimen daily for 5 weeks. The study includes three in-person evaluations and four weekly telehealth therapy sessions where participants perform peak cough flow assessments, respiratory exercises, and voice tests. After the active training period, a final evaluation is conducted, followed by a 6-month monthly telehealth follow-up to monitor progress and treatment adherence through daily logs. During the study, participants will complete various assessments including peak cough flow measurements, pulmonary function tests, maximum phonation time, and surveys on respiratory symptoms and ALS functional status. Telehealth sessions involve guided training and data collection via video calls, with devices provided for home use. The main outcome measured is peak cough flow from the initial baseline to the final evaluation over 10 weeks. Secondary measures include additional pulmonary function tests and cough spirometry. Safety and treatment adherence are monitored throughout the study and follow-up period, which extends total participation to about 7 months.

Combined Respiratory Training in Persons With ALS