Combined Respiratory Training for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how two specific breathing exercises—lung volume recruitment (which helps the lungs take in more air) and expiratory muscle strength training (which strengthens muscles used in breathing out)—can improve breathing and quality of life for people with ALS. Researchers aim to determine if these exercises strengthen coughing, ease breathing, and affect daily life for both patients and caregivers. This trial suits those diagnosed with ALS within the last two years who have trouble coughing and have not tried these specific breathing exercises before. As an unphased trial, it offers a unique opportunity to explore innovative breathing techniques that could enhance daily living for ALS patients and their caregivers.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are using prescription cough assist or non-invasive volume ventilation devices, you cannot participate in the trial.
What prior data suggests that this combined respiratory training is safe for ALS patients?
Research has shown that combined breathing exercises, which include techniques to expand the lungs and strengthen breathing muscles, are generally safe for people with ALS, a disease affecting the nervous system. Studies have found that these exercises can strengthen breathing muscles. For instance, one study found that a moderate-level breathing exercise program was manageable for participants and led to short-term improvements in muscle strength. Another study observed that exercises to expand the lungs improved lung function for a short time after treatment. These findings suggest that the combined exercises might be safe for participants, with no major safety concerns reported so far.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach to managing ALS through Combined Respiratory Training, which includes lung volume recruitment and expiratory muscle strength training. Unlike traditional ALS treatments that focus primarily on slowing disease progression or managing symptoms with medications like riluzole or edaravone, this method directly targets respiratory muscle function, potentially improving breathing capacity and quality of life. By integrating exercises that strengthen the muscles involved in breathing, this technique could offer a complementary benefit that current drug therapies do not provide. This trial could pave the way for innovative, non-pharmacological interventions that address specific physical challenges faced by ALS patients.
What evidence suggests that combined respiratory training is effective for ALS?
Research has shown that a combination of breathing exercises, which includes techniques to expand lung capacity and strengthen breathing muscles, can benefit people with ALS (amyotrophic lateral sclerosis). In this trial, all participants will follow a regimen of combined lung volume recruitment and expiratory muscle strength training. One study demonstrated that exercises to increase lung capacity significantly improved lung function for up to 15 minutes after the session. Another study found that training the breathing muscles increased their strength, particularly enhancing the ability to breathe out and breathe in forcefully. Specifically, one participant's ability to breathe in improved by 89% after this training. These findings suggest that combined breathing exercises could enhance breathing and muscle strength in people with ALS.12345
Who Is on the Research Team?
Magalie Thomas, MBA
Principal Investigator
Nova Southeastern University
Are You a Good Fit for This Trial?
This trial is for people with ALS who have had symptoms for less than 2 years, can't already use respiratory training devices, and don't have a tracheostomy or need invasive breathing support. They shouldn't be in other studies that affect coughing or breathing and must not have severe lung diseases like COPD.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening/Baseline 1
Participants are screened for eligibility to participate in the trial
Baseline 2
Introduction of LVR and EMST training with initial training session
Active Training
Weekly telehealth therapy sessions including LVR and EMST training, peak cough flow assessment, and patient-reported outcomes
Final Evaluation
Final assessment procedures identical to Baseline 2
Follow-up
Monthly telehealth visits for peak cough flow and maximum phonation time assessments, and clinician-administered surveys
What Are the Treatments Tested in This Trial?
Interventions
- Combined Respiratory Training
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Southeastern University
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator