Clinical trial NCT02710110: Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)
Official title: The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: ALS Association
First posted: 2016-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Expiratory Pressure will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
measure: Maximum Inspiratory Pressure will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
measure: Pulmonary function to measure the forced vital capacity (FVC) between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
measure: Sniff Nasal Inspiratory Pressure will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
measure: Pulmonary function to measure the peak expiratory flow (PEF) will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
measure: Pulmonary function to measure the forced expiratory volume (FEV1) will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
Secondary outcomes:
measure: The Penetration-aspiration scale will be used to measure swallowing function
timeFrame: Changes from baseline to month 3
measure: Lingual strength will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
measure: Lingual endurance will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
measure: Voluntary cough function will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
measure: Reflexive cough will be measured between the groups for a change from baseline to month 3
timeFrame: Changes from baseline to month 3
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands
state: Florida
Study officials:
affiliation: University of Florida
name: Emily K Plowman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: