Clinical trial NCT03824938: Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Official title: Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: exercise
aspirin
cooling
antipyretic
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a within-subject design double-blind RCT in which each participant receives 1 of 3 treatments at 3 timepoints (i.e., 3 separate days separated by 1-week washout periods).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Time-to-exhaustion
timeFrame: from start of exercise test until self-reported exhaustion, up to 30 minutes
measure: Exercise-induced Body Temperature Change
timeFrame: from start of exercise test until self-reported exhaustion, up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Victoria M Leavitt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leavitt VM, Blanchard AR, Guo CY, Gelernt E, Sumowski JF, Stein J. Aspirin is an effective pretreatment for exercise in multiple sclerosis: A double-blind randomized controlled pilot trial. Mult Scler. 2018 Oct;24(11):1511-1513. doi: 10.1177/1352458517739138. Epub 2017 Oct 27.
citation: Kever A, Nelson KE, Aguerre IM, Riley CS, Boehme A, Lee NW, Strauss Farber R, Levin SN, Stein J, Leavitt VM. ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis. BMJ Open. 2020 Nov 14;10(11):e039691. doi: 10.1136/bmjopen-2020-039691.