Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT03202017
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Study Start: 2018-03-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peak Cough Flow	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

Name	Time	Method
Maximal Expiratory Pressure	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)
Forced Vital Capacity	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)
Eating Assessment Tool - 10 (EAT-10)	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)
Swallowing Related Quality of Life (SWAL-QOL)	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)
Speech Intelligibility Test (SIT)	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).

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States