Status:
WITHDRAWN
Fatigue in Patients With Amyotrophic Lateral Sclerosis
Lead Sponsor:
Cara Donohue
Conditions:
Amyotrophic Lateral Sclerosis
Dysphagia
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Expiratory muscle strength training (EMST) is an emerging palliative intervention for prolonging pulmonary and swallow function in patients with amyotrophic lateral sclerosis (PALS), but it is unknown...
Detailed Description
This research proposal will determine the immediate impact of expiratory muscle strength training (EMST) on fatigue of the respiratory and swallowing musculature, whether objective decompensation tran...
Eligibility Criteria
Inclusion
- Diagnosis of ALS defined as possible, probable, or definite by a neurologist using the El Escorial criteria
- FVC\>65% predicted
- adequate cognition as defined by a score of \>10 on the ALS Cognitive Behavioral Screen
- adequate labial seal for completing pulmonary function tests and expiratory muscle strength training (EMST)
- on a regular/thin liquid diet
- no allergies to barium
- not oxygen-dependent
- no tracheostomy/ mechanical ventilation
- no history of other neurological or respiratory disorders
- no history of smoking
- no history of head and neck cancer or other major head/neck surgery or radiation therapy.
Exclusion
- FVC\<65% predicted
- inadequate cognition as defined by a score of \<10 on the ALS Cognitive Behavioral Screen -inadequate labial seal for completing pulmonary function tests and expiratory muscle strength training (EMST)
- not on a regular/thin liquid diet
- allergies to barium
- oxygen-dependent
- presence of tracheostomy/dependent on mechanical ventilation
- history of other neurological or respiratory disorders
- history of smoking
- history of head and neck cancer or other major head/neck surgery or radiation therapy.
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04468191
Start Date
February 10 2021
End Date
February 10 2021
Last Update
February 15 2021
Active Locations (1)
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1
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15260