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Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expiratory Muscle Strength Training (EMST)
EMST + Lung Volume Recruitment (LVR)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida
  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Expiratory Muscle Strength Testing (EMST)

EMST + Lung Volume Recruitment (LVR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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).

Full Information

First Posted
June 26, 2017
Last Updated
February 22, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03202017
Brief Title
Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
Official Title
A Pilot Study of Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expiratory Muscle Strength Testing (EMST)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EMST + Lung Volume Recruitment (LVR)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Expiratory Muscle Strength Training (EMST)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
EMST + Lung Volume Recruitment (LVR)
Intervention Description
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 Outcome Measure Information:
Title
Peak Cough Flow
Description
Ventilatory measure that assesses the change in coughing ability at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Time Frame
Baseline (Week 0), Week 6, and Week 12
Secondary Outcome Measure Information:
Title
Maximal Expiratory Pressure
Description
Measurement of respiratory muscle strength changes at Baseline (Week 0), Randomization (Week 6), Week 8, Week 10, and End of Study (Week 12)
Time Frame
Week 0, Week 6, Week 8, Week 10, and Week 12
Title
Forced Vital Capacity
Description
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)
Time Frame
Baseline (Week 0), Week 6, and Week 12
Title
Eating Assessment Tool - 10 (EAT-10)
Description
10-item patient reported outcome assessing changes in swallowing function at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Time Frame
Baseline (Week 0), Week 6, and Week 12
Title
Swallowing Related Quality of Life (SWAL-QOL)
Description
44-item patient reported outcome assessing changes in swallowing impairment at Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Time Frame
Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Title
Speech Intelligibility Test (SIT)
Description
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).
Time Frame
Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 0.7. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Walk, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

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