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Trial record 65 of 677 for:    amyotrophic lateral sclerosis

Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02710110
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
University of Florida

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).


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: PowerLung trainer Device: Micro Mouth Pressure Meter Procedure: Pulmonary Function Testing Procedure: Videofluoroscopic swallowing study Other: Swallowing Quality of Life Questionnaire Device: Iowa Oral Pressure Instrument Drug: Capsaicin Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : February 7, 2019


Arm Intervention/treatment
Experimental: Active Respiratory Trainer
Participants enrolled in this arm will be given the PowerLung trainer. The adjustable spring allows for discrete and calibrated changes to the valve, which in turn blocks air until sufficient inspiratory or expiratory pressure is applied by an individual. In addition, the Micro Mouth Pressure Meter, Pulmonary Function testing, videofluoroscopic swallowing study (VFSS), Swallowing Quality of Life Questionnaire (SWAL-QOL), Iowa Oral Pressure Instrument (IOPI), and capsaicin for use in the reflexive cough test.
Device: PowerLung trainer
PowerLung trainer will be utilized which has both an inspiratory and expiratory loading capacity for training. A single daily training session will consist of three sets of 10 repetitions for a total of 30 inspiratory repetitions and 30 expiratory repetitions (i.e. 60 repetitions) for 5 days a week, for 3 months.

Device: Micro Mouth Pressure Meter
The participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flange rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest Maximum Inspiratory Pressures (MIP) and Maximal Expiratory Pressure (MEP) used.
Other Names:
  • digital manometer
  • Micro Medical device

Procedure: Pulmonary Function Testing
Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values.

Procedure: Videofluoroscopic swallowing study
Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
Other Names:
  • VFSS
  • X-ray of swallowing

Other: Swallowing Quality of Life Questionnaire
Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.
Other Name: SWAL-QOL

Device: Iowa Oral Pressure Instrument
The IOPI is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
Other Name: IOPI

Drug: Capsaicin
A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.
Other Name: Hot pepper

Sham Comparator: Sham Trainer
Participants enrolled in this arm will be given the PowerLung trainer; however, the adjustable spring allows for discrete and calibrated changes to the valve and these will not have any resistance. In addition, the Micro Mouth Pressure Meter, Pulmonary Function testing, videofluoroscopic swallowing study (VFSS), Swallowing Quality of Life Questionnaire (SWAL-QOL), Iowa Oral Pressure Instrument (IOPI), and capsaicin for use in the reflexive cough test.
Device: PowerLung trainer
PowerLung trainer will be utilized which has both an inspiratory and expiratory loading capacity for training. A single daily training session will consist of three sets of 10 repetitions for a total of 30 inspiratory repetitions and 30 expiratory repetitions (i.e. 60 repetitions) for 5 days a week, for 3 months.

Device: Micro Mouth Pressure Meter
The participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flange rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest Maximum Inspiratory Pressures (MIP) and Maximal Expiratory Pressure (MEP) used.
Other Names:
  • digital manometer
  • Micro Medical device

Procedure: Pulmonary Function Testing
Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values.

Procedure: Videofluoroscopic swallowing study
Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
Other Names:
  • VFSS
  • X-ray of swallowing

Other: Swallowing Quality of Life Questionnaire
Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.
Other Name: SWAL-QOL

Device: Iowa Oral Pressure Instrument
The IOPI is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
Other Name: IOPI

Drug: Capsaicin
A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.
Other Name: Hot pepper




Primary Outcome Measures :
  1. Maximum Expiratory Pressure will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    Maximum expiratory pressure is a measure of force generating capabilities as assessed by having subjects quickly inhale then rapidly blow out air into a handheld manometer (Micro Mouth Pressure Meter). Three trails will be performed and the highest will be used.

  2. Maximum Inspiratory Pressure will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    Maximum inspiratory pressure is a measure of force generating capabilities as assessed by having subjects quickly inhale then rapidly blow out air into a handheld manometer (Micro Mouth Pressure Meter). Three trails will be performed and the highest will be used.

  3. Pulmonary function to measure the forced vital capacity (FVC) between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete forced vital capacity (FVC) expressed as a percentage of predicted values.

  4. Sniff Nasal Inspiratory Pressure will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
  5. Pulmonary function to measure the peak expiratory flow (PEF) will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete peak expiratory flow (PEF) expressed as a percentage of predicted values.

  6. Pulmonary function to measure the forced expiratory volume (FEV1) will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    Pulmonary Function testing will be performed using a micro pressure meter. The participant will perform a maximum inhalation and then slowly blow out air into the mouthpiece of the meter. The following measurement will be displayed on the meter after the exhalation is complete forced expiratory volume (FEV1) expressed as a percentage of predicted values.


Secondary Outcome Measures :
  1. The Penetration-aspiration scale will be used to measure swallowing function [ Time Frame: Changes from baseline to month 3 ]
    Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.

  2. Lingual strength will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    The Iowa Oral Pressure Instrument device will measure the peak performance of lingual strength a via the action of a bulb placed on the hard palate. To assess maximum anterior isometric pressure, the bulb will be placed on the roof of the mouth and the participant will raise his or her tongue to apply pressure to this bulb and then quickly release the tongue back into a neutral position. This repetitive tongue movement will be performed three times and values will be recorded.

  3. Lingual endurance will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    The Iowa Oral Pressure Instrument device will measure the peak performance of maximum lingual endurance time by instructing the participant to place the bulb on the roof of the mouth and then apply and sustain pressure to the bulb for as long as he/she can at a threshold of 20% of the maximum anterior isometric pressure. The maximum lingual endurance time will also be recorded.

  4. Voluntary cough function will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    Voluntary cough function will be assessed using an oral pneumotachograph, connected to a spirometer filter during voluntary cough production. The participant will be seated with a respiratory face-mask held in place by the examiner and instructed to complete three tidal breaths into the face-mask, airflow signal will be measured

  5. Reflexive cough will be measured between the groups for a change from baseline to month 3 [ Time Frame: Changes from baseline to month 3 ]
    Reflexive cough will be assessed using an oral pneumotachograph, differential pressure transducer, and have a side port with a one-way inspiratory valve for nebulizer connection. The nebulizer will deliver three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710110


Locations
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United States, Florida
UF Health Shands
Gainesville, Florida, United States, 32605
Sponsors and Collaborators
University of Florida
ALS Association
Investigators
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Principal Investigator: Emily K Plowman, Ph.D. University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02710110     History of Changes
Other Study ID Numbers: IRB201501172
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs