Skip to main content
OpenTrials
Completed

NCT Number: NCT03202017

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 28, 2017
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.