Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202017
• Other study ID #: NEUR-2017-25778
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)