NCT05913882 · Nova Southeastern University
Combined Respiratory Training in Persons With ALS
What this study is about
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. Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS. 2.
View original scientific description
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. Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS. 2. Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment. 3. Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.
Interventions
DEVICE
Respiratory Muscle Strength Training (LVR+EMST)
Combined respiratory muscle strength training regimen that will be completed daily for 5 weeks.
Primary outcome measures
Peak Cough Flow
Time frame: From Baseline 1 to Final Evaluation (10 weeks)
Greatest cough measurement measured in liters/minute.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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).
Where
- Fort Lauderdale, Florida
Collaborators
Congressionally Directed Medical Research Programs
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations