ALSNCT05913882
Combined Respiratory Training in Persons With ALS
A study testing Respiratory Muscle Strength Training (LVR+EMST) in people with ALS and Respiratory Insufficiency, run by Nova Southeastern University at 1 site in United States.
Trial summary
The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ALS, Respiratory Insufficiency, Dysphagia
- What is being tested?
- Respiratory Muscle Strength Training (LVR+EMST)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria.
- Disease duration from symptom onset of ≤ 2 years,
- Lung volume recruitment and expiratory muscle strength training naïve,
- Reduced peak cough flow (% predicted for age and gender).
Who cannot join
- History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment.
- Use of prescription cough assist or non-invasive volume ventilation devices.
- Enrollment in another research investigation that might impact cough or respiratory function.
- Diagnosis of frontotemporal dementia or advanced cognitive impairment.
- Tracheostomy placement/Use of invasive mechanical ventilation.
- Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nova Southeastern University
Fort Lauderdale, Florida, 33314
Lauren Tabor Gray, PhD, 954 262 6387, Lgray1@nova.edu
Donovan Mott, 954-203-2829, donovan.mott@nova.edu
About this study
Official title: Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons With ALS
The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed:
- Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS.
- Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment.
- Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.
Read the detailed description
In this delayed start, repeated-measures design, pALS will serve as their own control to provide treatment to all participants and control for disease heterogeneity (i.e., interparticipant differences). Participation will include three in-person evaluations and four weekly telehealth therapy sessions (Figure 3). Weekly telehealth therapy sessions will include home peak cough flow assessment, LVR and EMST training sessions to ensure treatment fidelity, maximum phonation time as a surrogate measure of forced vital capacity, and patient-reported outcomes including the ALS Respiratory Symptom Scale. To assess peak cough flow at home, participants will be provided with a commercially available peak cough flow meter (MiniWright, PF100) for guided assessment during telehealth appointments.
Study Timeline.
Study assessments and procedures at each time point are briefly described below and depicted in Table 1.
Screening/Baseline 1 (Week -5).
Following consenting and screening procedures, study personnel will complete the initial baseline assessment procedures. Participants will complete the initial baseline assessment in approximately 60-90 minutes.
Baseline 2 (Week 0).
The Baseline 2 appointment will consist of the identical assessment procedures conducted in the same order as Baseline 1. LVR and EMST training will be introduced and the first training session will be completed during the appointment. Participants will complete the Baseline 2 appointment in ~100-120 minutes.
Telehealth Appointments (Active Training Weeks 0-5).
Weekly telehealth therapy appointments will be conducted during the active training period using the Zoom platform (Zoom Video Communications, Inc). During these sessions, the research clinician will lead a LVR and EMST training session with the participant, complete peak cough flow and maximum sustained phonation testing, and administered surveys including the ALS Functional Rating Scale- Revised and the ALS Respiratory Symptom Scale. Surveys will be screen shared with the participants and data will be recorded on the source documents by the research clinician.
Final Evaluation (Week 5).
The Final Evaluation appointment will consist of the identical assessment procedures conducted in the same order as Baseline 2.
Follow-up Period (6-months).
The follow-up period consists of monthly telehealth visits with the research clinician. Participants who complete the initial 10-week study period will be asked to participate in follow-up. These telehealth visits will include peak cough flow and maximum phonation time assessments, and clinician-administered surveys. During this period, treatment adherence will be tracked using the same daily treatment logs, which will be reviewed during monthly appointments.
- Conditions
- ALS, Respiratory Insufficiency, Dysphagia
- Being tested
- Respiratory Muscle Strength Training (LVR+EMST)
- Keywords
- Breathing, Swallowing, Exercise, Bulbar
- Medical subject headings
- Respiratory Insufficiency, Deglutition Disorders, Respiratory Aspiration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle Strength Training (LVR+EMST)Device
Combined respiratory muscle strength training regimen that will be completed daily for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lung Volume Recruitment +Expiratory Muscle Strength Training | Experimental | All enrolled participants will commence a combined lung volume recruitment and expiratory muscle strength training exercise regimen following a 5-week no-intervention lead-in period. Receives: Device: Respiratory Muscle Strength Training (LVR+EMST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Cough Flow
Greatest cough measurement measured in liters/minute.
Measured: From Baseline 1 to Final Evaluation (10 weeks)
Secondary outcomes (4)
Cough Spirometry
Airflow parameters will be collected during voluntary cough production. The primary outcome obtained from voluntary cough spirometry will be cough volume acceleration (L/s/s), which is an aggregation of peak expiratory flow rate and peak expiratory rise time.
Measured: From Baseline 2 to Final Evaluation (5 weeks)
Pulmonary Function Assessment
Vital capacity with and without LVR. Forced vital capacity will be assessed before and after lung volume recruitment and the measurements will be used to determine the difference between FVC and FVC LIC (% predicted age/gender).
Measured: From Baseline 1 to Final Evaluation (10 weeks)
Pulmonary Function Assessment
Maximum respiratory pressure will be obtained to assess inspiratory and expiratory muscle strength (cmH20).
Measured: From Baseline 1 to Final evaluation (10 weeks)
Pulmonary Function Assessment
Maximum phonation time involves the participant sustaining the vowel /ah/ for as long as possible (seconds).
Measured: From Baseline 1 to Final evaluation (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start22 Aug 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Lauren Tabor Gray, PhD, Nova Southeastern University
- Investigators
- Magalie Thomas, MBA, Study chair, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913882
- Sponsor's protocol ID
- AL220099
- Status last verified
- Dec 2025
- First submitted
- 22 May 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared with credentialed individuals upon request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons With ALS
- ClinicalTrials.gov ID
- NCT05913882
- Acronym / sponsor ID
- AL220099
- Conditions
- ALS, Respiratory Insufficiency, Dysphagia
- Keywords
- Breathing, Swallowing, Exercise, Bulbar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Jun 2023 (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 goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed:
- Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS.
- Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment.
- Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.
Detailed description
In this delayed start, repeated-measures design, pALS will serve as their own control to provide treatment to all participants and control for disease heterogeneity (i.e., interparticipant differences). Participation will include three in-person evaluations and four weekly telehealth therapy sessions (Figure 3). Weekly telehealth therapy sessions will include home peak cough flow assessment, LVR and EMST training sessions to ensure treatment fidelity, maximum phonation time as a surrogate measure of forced vital capacity, and patient-reported outcomes including the ALS Respiratory Symptom Scale. To assess peak cough flow at home, participants will be provided with a commercially available peak cough flow meter (MiniWright, PF100) for guided assessment during telehealth appointments.
Study Timeline.
Study assessments and procedures at each time point are briefly described below and depicted in Table 1.
Screening/Baseline 1 (Week -5).
Following consenting and screening procedures, study personnel will complete the initial baseline assessment procedures. Participants will complete the initial baseline assessment in approximately 60-90 minutes.
Baseline 2 (Week 0).
The Baseline 2 appointment will consist of the identical assessment procedures conducted in the same order as Baseline 1. LVR and EMST training will be introduced and the first training session will be completed during the appointment. Participants will complete the Baseline 2 appointment in ~100-120 minutes.
Telehealth Appointments (Active Training Weeks 0-5).
Weekly telehealth therapy appointments will be conducted during the active training period using the Zoom platform (Zoom Video Communications, Inc). During these sessions, the research clinician will lead a LVR and EMST training session with the participant, complete peak cough flow and maximum sustained phonation testing, and administered surveys including the ALS Functional Rating Scale- Revised and the ALS Respiratory Symptom Scale. Surveys will be screen shared with the participants and data will be recorded on the source documents by the research clinician.
Final Evaluation (Week 5).
The Final Evaluation appointment will consist of the identical assessment procedures conducted in the same order as Baseline 2.
Follow-up Period (6-months).
The follow-up period consists of monthly telehealth visits with the research clinician. Participants who complete the initial 10-week study period will be asked to participate in follow-up. These telehealth visits will include peak cough flow and maximum phonation time assessments, and clinician-administered surveys. During this period, treatment adherence will be tracked using the same daily treatment logs, which will be reviewed during monthly appointments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Volume Recruitment +Expiratory Muscle Strength Training | Experimental | Device: Respiratory Muscle Strength Training (LVR+EMST)All enrolled participants will commence a combined lung volume recruitment and expiratory muscle strength training exercise regimen following a 5-week no-intervention lead-in period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria.
- Disease duration from symptom onset of ≤ 2 years,
- Lung volume recruitment and expiratory muscle strength training naïve,
- Reduced peak cough flow (% predicted for age and gender).
Key exclusion criteria (6 listed)
- History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment.
- Use of prescription cough assist or non-invasive volume ventilation devices.
- Enrollment in another research investigation that might impact cough or respiratory function.
- Diagnosis of frontotemporal dementia or advanced cognitive impairment.
- Tracheostomy placement/Use of invasive mechanical ventilation.
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 |
|---|---|---|
| Respiratory Muscle Strength Training (LVR+EMST)Combined respiratory muscle strength training regimen that will be completed daily for 5 weeks. | Device | Lung Volume Recruitment +Expiratory Muscle Strength Training |
Primary outcome
Peak Cough Flow
Time frame: From Baseline 1 to Final Evaluation (10 weeks)
Greatest cough measurement measured in liters/minute.
4 secondary outcomes
Cough Spirometry
Time frame: From Baseline 2 to Final Evaluation (5 weeks)
Pulmonary Function Assessment
Time frame: From Baseline 1 to Final Evaluation (10 weeks)
Pulmonary Function Assessment
Time frame: From Baseline 1 to Final evaluation (10 weeks)
Pulmonary Function Assessment
Time frame: From Baseline 1 to Final evaluation (10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Nova ALS ClinicLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with credentialed individuals upon request.
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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.
Magalie Thomas, MBA study chair
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscle Strength Training (LVR+EMST) in people with ALS and Respiratory Insufficiency, run by Nova Southeastern University at 1 site 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Tabor Gray, PhD (954-262-8963, Lgray1@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Cough Flow (time frame: From Baseline 1 to Final Evaluation (10 weeks)). 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 Dec 2025.