Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

A Pilot Study of Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Procedure: Expiratory Muscle Strength Training (EMST); Procedure: EMST + Lung Volume Recruitment (LVR)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Cough Flow	Ventilatory measure that assesses the change in coughing ability at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)	Baseline (Week 0), Week 6, and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Expiratory Pressure	Measurement of respiratory muscle strength changes at Baseline (Week 0), Randomization (Week 6), Week 8, Week 10, and End of Study (Week 12)	Week 0, Week 6, Week 8, Week 10, and Week 12
Forced Vital Capacity	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)	Baseline (Week 0), Week 6, and Week 12
Eating Assessment Tool - 10 (EAT-10)	10-item patient reported outcome assessing changes in swallowing function at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)	Baseline (Week 0), Week 6, and Week 12
Swallowing Related Quality of Life (SWAL-QOL)	44-item patient reported outcome assessing changes in swallowing impairment at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)	Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Speech Intelligibility Test (SIT)	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).	Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: David Walk, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: NEUR-2017-25778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No