Combined Respiratory Training in Persons With ALS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNova Southeastern University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Respiratory Muscle Strength Training (LVR+EMST)
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Nova Southeastern University
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov