Multiple Sclerosis Clinical Trial
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
This study investigates the use of aspirin as an exercise pre-treatment to reduce overheating and exhaustion, which may potentially allow many more people with multiple sclerosis to participate in and benefit from exercise. The design is double-blind, within-subject, with three arms: participants will receive one of three treatments at three separate study visits: aspirin, acetaminophen, and placebo, followed by completion of a maximal exercise test.
Persons with multiple sclerosis benefit from exercise, but many avoid it because of exhaustion and overheating. This randomized controlled trial (RCT) tests aspirin as a method to increase time to exhaustion for persons with MS, through its antipyretic mechanism. Participants will be seen at our laboratory for maximal exercise tests on three separate days. At each session, they will be given one of three treatments: aspirin, acetaminophen (a drug that is anti-inflammatory but not antipyretic, thereby allowing for isolation of the antipyretic action of aspirin), and placebo. Primary outcome is increased time to exhaustion, secondary outcome is reduced body temperature increase during exercise.
Diagnosis of relapsing-remitting MS
self-reported heat-sensitivity to exercise
Expanded Disability Status Scale (EDSS) total score ≤ 6.0
exacerbation-free (and no use of corticosteroids) for 6 weeks prior
BMI ≤ 40
prior history of significant head injury, stroke, or other neurological disease/disorder
current daily use of antipyretics or pain medication
currently in a major depressive episode
vascular disease of the legs, uncontrolled high blood pressure
uncontrolled diabetes mellitus or problem with blood sugar levels
contraindications to aspirin use (history of confirmed peptic ulcer, gastrointestinal or severe gynecological bleeding)
tarry stool or known fecal occult blood
uncontrolled syndrome of asthma, rhinitis, or nasal polyps
contraindications to acetaminophen use (severe active hepatic disease, Hepatitis C Virus)
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There is 1 Location for this study
New York New York, 10032, United States
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