Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - 85 |
| Updated: | 2/10/2019 |
| Start Date: | April 2016 |
| End Date: | February 7, 2019 |
The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)
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).
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).
This research study will measure the maximum inspiratory and expiratory pressure with
secondary measures of respiration, swallow, cough, quality of life and global disease
progression following twelve-weeks of treatment compared to the sham group.
As a participant two evaluations at the University of Florida Swallowing Systems Core
laboratory located at Shands Hospital, Gainesville will take place. Each will take
approximately two-hours and these will be spaced exactly three-months apart. During each
evaluation tests will be performed to look at breathing, swallowing, and ability to cough
doing standard clinical exams. In addition, some surveys about eating, speaking and quality
of life will be taken.
Breathing Exercises: a home research therapist will train the participants how to use the
hand-held respiratory trainer. Training for both treatment groups will be very similar,
except the PowerLung trainer device will have an additional spring load valve inside it that
will place a force on the respiratory muscles during training. The other breathing trainer
will not have this spring so that no resistance will be placed on the respiratory muscles
during training and this will represent an aerobic respiratory treatment. The breathing
exercises will be completed five days a week for a total of three months (a total of 60
therapy sessions). During each session, a total of three sets of ten repetitions of breathing
exercises will be performed. Once a week the home research therapist will visit and guide
participants through the breathing exercise.
secondary measures of respiration, swallow, cough, quality of life and global disease
progression following twelve-weeks of treatment compared to the sham group.
As a participant two evaluations at the University of Florida Swallowing Systems Core
laboratory located at Shands Hospital, Gainesville will take place. Each will take
approximately two-hours and these will be spaced exactly three-months apart. During each
evaluation tests will be performed to look at breathing, swallowing, and ability to cough
doing standard clinical exams. In addition, some surveys about eating, speaking and quality
of life will be taken.
Breathing Exercises: a home research therapist will train the participants how to use the
hand-held respiratory trainer. Training for both treatment groups will be very similar,
except the PowerLung trainer device will have an additional spring load valve inside it that
will place a force on the respiratory muscles during training. The other breathing trainer
will not have this spring so that no resistance will be placed on the respiratory muscles
during training and this will represent an aerobic respiratory treatment. The breathing
exercises will be completed five days a week for a total of three months (a total of 60
therapy sessions). During each session, a total of three sets of ten repetitions of breathing
exercises will be performed. Once a week the home research therapist will visit and guide
participants through the breathing exercise.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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