Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

NCT03202017 | Completed

• 1 other identifier: NEUR-2017-25778
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Maximal Expiratory Pressure

  Week 0, Week 6, Week 8, Week 10, and Week 12

• Forced Vital Capacity

  Baseline (Week 0), Week 6, and Week 12

• Eating Assessment Tool - 10 (EAT-10)

  Baseline (Week 0), Week 6, and Week 12

• Swallowing Related Quality of Life (SWAL-QOL)

  Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)

• Speech Intelligibility Test (SIT)

  Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)

Study Arms (2)

Expiratory Muscle Strength Testing (EMST)

ACTIVE COMPARATOR

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 + Lung Volume Recruitment (LVR)

ACTIVE COMPARATOR

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)

Interventions

Expiratory Muscle Strength Training (EMST) PROCEDURE

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.

Expiratory Muscle Strength Testing (EMST)

EMST + Lung Volume Recruitment (LVR) PROCEDURE

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.

EMST + Lung Volume Recruitment (LVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Walk, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: March 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)