RecruitingNot ApplicableNCT05913882

Combined Respiratory Training in Persons With ALS

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


Sponsor

Nova Southeastern University

Enrollment

34 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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).

Interventions

DEVICERespiratory Muscle Strength Training (LVR+EMST)

Combined respiratory muscle strength training regimen that will be completed daily for 5 weeks.


Locations(1)

Nova Southeastern University

Fort Lauderdale, Florida, United States

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NCT05913882


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