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Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

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ClinicalTrials.gov Identifier: NCT03202017
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The purpose of this study is to investigate the effects of two treatment techniques called Expiratory Muscle Strength Training (EMST) and Lung Volume Recruitment (LVR) on breathing, swallowing, speech, and cough function in persons with mild to moderate ALS. Half of the participants will do EMST alone, and the other half of the participants will do EMST and LVR.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: Expiratory Muscle Strength Training (EMST) Procedure: EMST + Lung Volume Recruitment (LVR) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Active Comparator: Expiratory Muscle Strength Testing (EMST)
EMST is a treatment method that has been used to improve cough function and swallowing in ALS. EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week.
Procedure: Expiratory Muscle Strength Training (EMST)
EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week.

Active Comparator: EMST + Lung Volume Recruitment (LVR)

EMST is a treatment method that has been used to improve cough function and swallowing in ALS. EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week.

LVR is a technique to increase cough function that is performed with a resuscitation bag fitted with a mouthpiece and a one-way valve. The bag is used to expand the lungs, after which the patient makes a voluntary cough.

Procedure: EMST + Lung Volume Recruitment (LVR)

EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week.

LVR is a technique to increase cough function that is performed with a resuscitation bag fitted with a mouthpiece and a one-way valve. The bag is used to expand the lungs, after which the patient makes a voluntary cough. Half of the participants will perform the LVR technique in addition to the ESMT technique.





Primary Outcome Measures :
  1. Peak Cough Flow [ Time Frame: Baseline (Week 0), Week 6, and Week 12 ]
    Ventilatory measure that assesses the change in coughing ability at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)


Secondary Outcome Measures :
  1. Maximal Expiratory Pressure [ Time Frame: Week 0, Week 6, Week 8, Week 10, and Week 12 ]
    Measurement of respiratory muscle strength changes at Baseline (Week 0), Randomization (Week 6), Week 8, Week 10, and End of Study (Week 12)

  2. Forced Vital Capacity [ Time Frame: Baseline (Week 0), Week 6, and Week 12 ]
    Measurement of changes in how much air is exhaled over a series of forced breaths at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)

  3. Eating Assessment Tool - 10 (EAT-10) [ Time Frame: Baseline (Week 0), Week 6, and Week 12 ]
    10-item patient reported outcome assessing changes in swallowing function at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)

  4. Swallowing Related Quality of Life (SWAL-QOL) [ Time Frame: Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12) ]
    44-item patient reported outcome assessing changes in swallowing impairment at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)

  5. Speech Intelligibility Test (SIT) [ Time Frame: Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12) ]
    Standardized assessment of speech intelligibility and efficiency in neuromuscular disorders. Measures changes in speech intelligibility at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ALS defined as possible, laboratory-supported probable, probable, or definite by El Escorial criteria
  • Reduced Maximal Expiratory Pressure (MEP) compared to norms for age and sex
  • Forced Vital Capacity (FVC) > 65% predicted

Exclusion Criteria:

  • Inability to provide informed consent
  • Relative contraindications to LVR, including known pneumothorax, active internal bleeding, unstable hypertension, unstable angina, emphysema, recent barotrauma, or FEV1 (Forced Expiratory Volume, trial 1)/FVC ratio < 0.7.
  • Use of EMST or breath stacking > 3 days/week within 12 weeks of screening
  • Amyotrophic Lateral Sclerosis-Cognitive Behavioral Scale (ALS-CBS) score predictive of dementia (≤ 10)
  • Participation in another clinical trial of an intervention in ALS within 30 days of study enrollment or during study enrollment

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): NCT03202017


Contacts
Contact: Valerie Ferment 612-301-1535 alsresearch@umn.edu

Locations
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Kelby Magennis, MPH    352-273-8632    kmagennis@phhp.ufl.edu   
Principal Investigator: Emily Plowman, PhD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Valerie Ferment    612-301-1535    alsresearch@umn.edu   
Principal Investigator: David Walk, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: David Walk, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03202017     History of Changes
Other Study ID Numbers: NEUR-2017-25778
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases