Breathing and swallowing training for people with ALS

Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons With ALS

This study is testing if breathing and swallowing training can help people with ALS breathe better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Nova Southeastern University (Academic / other)
• Locations: 1 site (Fort Lauderdale, Florida)
• Trial ID: NCT05913882 on ClinicalTrials.gov

What this trial studies

This interventional trial aims to evaluate the effects of combined lung volume recruitment (LVR) and expiratory muscle strength training (EMST) on respiratory function and quality of life in patients diagnosed with ALS. The study will involve up to 39 participants who will undergo a series of assessments and telehealth therapy sessions to monitor cough strength, dyspnea, and overall well-being. Participants will serve as their own controls, allowing for a more accurate assessment of the treatment's impact over time. The trial includes both in-person evaluations and remote training sessions to ensure adherence and effectiveness.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with probable or definite ALS within two years of symptom onset who have not previously undergone LVR or EMST training.

Not a fit: Patients with advanced cognitive impairment, tracheostomy, or those using invasive mechanical ventilation are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve respiratory function and quality of life for patients with ALS.

How similar studies have performed: While similar approaches have been explored, this specific combination of LVR and EMST in ALS patients is relatively novel and has not been extensively tested.

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).

Where this trial is running

Fort Lauderdale, Florida

• Nova Southeastern University — Fort Lauderdale, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Lauren Tabor Gray, PhD

Conditions ALS; Respiratory Insufficiency; Dysphagia; Breathing; Swallowing; Exercise; Bulbar