Amyotrophic Lateral SclerosisNCT03202017
Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
A study testing Expiratory Muscle Strength Training (EMST) and EMST + Lung Volume Recruitment (LVR) in people with Amyotrophic Lateral Sclerosis, run by University of Minnesota at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Expiratory Muscle Strength Training (EMST) and EMST + Lung Volume Recruitment (LVR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2018to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32611
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Pilot Study of 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Expiratory Muscle Strength Training (EMST), EMST + Lung Volume Recruitment (LVR)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Muscle Strength Training (EMST)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Expiratory Muscle Strength Testing (EMST) | Active comparator | 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. Receives: Procedure: Expiratory Muscle Strength Training (EMST) |
| EMST + Lung Volume Recruitment (LVR) | Active comparator | 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. Receives: Procedure: EMST + Lung Volume Recruitment (LVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (Week 0), Week 6, and Week 12
Secondary outcomes (5)
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)
Measured: Week 0, Week 6, Week 8, Week 10, and 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)
Measured: Baseline (Week 0), Week 6, and 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)
Measured: Baseline (Week 0), Week 6, and 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)
Measured: 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).
Measured: Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Mar 2018
- Primary completion1 Dec 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Walk, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202017
- Sponsor's protocol ID
- NEUR-2017-25778
- Status last verified
- Feb 2023
- First submitted
- 26 Jun 2017
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
- ClinicalTrials.gov ID
- NCT03202017
- Acronym / sponsor ID
- NEUR-2017-25778
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expiratory Muscle Strength Testing (EMST) | Active comparator | Procedure: Expiratory Muscle Strength Training (EMST)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 + Lung Volume Recruitment (LVR) | Active comparator | Procedure: EMST + Lung Volume Recruitment (LVR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Expiratory Muscle Strength Testing (EMST) |
| 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. | Procedure or surgery | EMST + Lung Volume Recruitment (LVR) |
Primary outcome
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)
5 secondary outcomes
Maximal Expiratory Pressure
Time frame: Week 0, Week 6, Week 8, Week 10, and Week 12
Forced Vital Capacity
Time frame: Baseline (Week 0), Week 6, and Week 12
Eating Assessment Tool - 10 (EAT-10)
Time frame: Baseline (Week 0), Week 6, and Week 12
Swallowing Related Quality of Life (SWAL-QOL)
Time frame: Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Speech Intelligibility Test (SIT)
Time frame: Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Walk, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Muscle Strength Training (EMST) and EMST + Lung Volume Recruitment (LVR) in people with Amyotrophic Lateral Sclerosis, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Cough Flow (time frame: Baseline (Week 0), Week 6, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.