Fatigue in Patients With Amyotrophic Lateral Sclerosis
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Amyotrophic Lateral Sclerosis, Dysphagia, Dyspnea, Respiration Disorders
In brief
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 whether EMST may result in detrimental immediate to short-term fatigue because there is no way to measure fatigue non-invasively. This study will determine the immediate to short-term impact of EMST on objective respiratory and swallow function, whether subjective ratings of dyspnea and fatigue map to objective decompensation of respiratory and swallow function, and the ability to monitor fatigue of the respiratory and swallowing musculature non-invasively. Findings from this research study will provide preliminary evidence regarding optimal timing for PALS to complete EMST and will provide PALS and clinicians increased capabilities to monitor fatigue non-invasively.
Key facts
- Study ID
- NCT04468191
- Run by
- Cara Donohue
- People needed
- 0
- Starts
- 2021-02-10
- Expected to finish
- 2021-02-10
- Last updated by the study team
- 2021-02-15
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Pittsburgh Medical Center Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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