Combined Respiratory Training in Persons with ALS
Launched by NOVA SOUTHEASTERN UNIVERSITY · Jun 13, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called "Combined Respiratory Training in Persons with ALS," is exploring how two specific types of training—lung volume recruitment (LVR) and expiratory muscle strength training (EMST)—can help improve cough strength and breathing in people with ALS (Amyotrophic Lateral Sclerosis). The study aims to understand how these training methods can not only enhance lung function but also reduce feelings of breathlessness and improve overall quality of life for both patients and their caregivers.
To participate in this trial, individuals should be diagnosed with ALS within the last two years and should not have previously undergone these types of respiratory training. Participants will be closely monitored to see how their cough strength and respiratory function change during the training, and they will also share their experiences regarding any difficulties they face with swallowing or breathing. This study is currently recruiting participants aged between 18 and 75, regardless of gender, and it is important to note that those with certain other medical conditions may not be eligible. Overall, the trial provides an opportunity for ALS patients to contribute to research that could lead to better management of respiratory issues related to their condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria.
- • 2. Disease duration from symptom onset of ≤ 2 years,
- • 3. Lung volume recruitment and expiratory muscle strength training naïve,
- • 4. Reduced peak cough flow (% predicted for age and gender).
- Exclusion Criteria:
- • 1. History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment.
- • 2. Use of prescription cough assist or non-invasive volume ventilation devices.
- • 3. Enrollment in another research investigation that might impact cough or respiratory function.
- • 4. Diagnosis of frontotemporal dementia or advanced cognitive impairment.
- • 5. Tracheostomy placement/Use of invasive mechanical ventilation.
- • 6. Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease).
About Nova Southeastern University
Nova Southeastern University (NSU) is a prominent academic institution dedicated to advancing healthcare through innovative research and education. With a strong emphasis on interdisciplinary collaboration, NSU conducts clinical trials that address critical health challenges and contribute to the development of new therapeutic strategies. The university's commitment to excellence in research is reflected in its state-of-the-art facilities and a diverse team of experienced professionals dedicated to ethical and impactful clinical investigation. Through its robust clinical trial programs, NSU aims to enhance patient outcomes and foster advancements in medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fort Lauderdale, Florida, United States
Patients applied
Trial Officials
Magalie Thomas, MBA
Study Chair
Nova Southeastern University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported