Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4% of ALS mortality. Unfortunately, treatments to prolong and maintain these vital functions are currently lacking. Although the use of exercise in ALS is controversial, recent evidence suggests that mild to moderate intensity exercise applied early in the disease slows disease progression, improves motor function, preserves motor neuron number, reduces muscle hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of ALS and human clinical trials. This research study is designed to determine the impact of respiratory strength training on breathing, airway protection and swallowing in persons with Amyotrophic Lateral Sclerosis (ALS).
Key facts
- Study ID
- NCT02710110
- Run by
- University of Florida
- People needed
- 50
- Starts
- 2016-04-01
- Expected to finish
- 2019-02-07
- Last updated by the study team
- 2020-01-27
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS),
- Amyotrophic Lateral Sclerosis Rating Scale Revised score greater than 34,
- forced vital capacity greater than 70%,
- cognition within normal limits as determined by Montreal assessment of cognition score >25
You may not qualify if…
- allergies to barium,
- tracheotomy or mechanical ventilation,
- diaphragmatic pacer,
- concurrent respiratory disease (e.g. COPD),
- pregnant at the time of the study due to radiation exposure
Where it is running
- UF Health Shands — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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