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

University of Minnesota2 sites in 1 country23 target enrollmentMarch 1, 2018

ConditionsAmyotrophic Lateral Sclerosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Amyotrophic Lateral Sclerosis
Sponsor: University of Minnesota
Enrollment: 23
Locations: 2
Primary Endpoint: Peak Cough Flow
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2018

End Date

December 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

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.
•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

Outcomes

Primary Outcomes

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

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))