Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Aspirin
Cyclooxygenase inhibitor
Compared with
- Acetaminophen
Anandamide amidohydrolase inhibitor|Cyclooxygenase inhibitor|Vanilloid receptor opener
Placebo
- Placebo
Results by group
Time-to-exhaustion
from start of exercise test until self-reported exhaustion, up to 30 minutes
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 551.7 seconds | 78.4 (Standard Deviation) | 32 |
| Aspirin | 331.6 seconds | 76.6 (Standard Deviation) | 31 |
| Acetaminophen | 578.2 seconds | 82.1 (Standard Deviation) | 32 |
Placebo
Aspirin
Acetaminophen
Exercise-induced Body Temperature Change
from start of exercise test until self-reported exhaustion, up to 30 minutes
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0.68 degrees Fahrenheit | 0.35 (Standard Deviation) | 32 |
| Aspirin | 0.006 degrees Fahrenheit | 0.32 (Standard Deviation) | 31 |
| Acetaminophen | 0.31 degrees Fahrenheit | 0.35 (Standard Deviation) | 32 |
Placebo
Aspirin
Acetaminophen
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 32 | 0 (0.0%) | 0 |
| Aspirin | 31 | 0 (0.0%) | 0 |
| Acetaminophen | 32 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Time-to-exhaustion
from start of exercise test until self-reported exhaustion, up to 30 minutes
Exercise-induced Body Temperature Change
from start of exercise test until self-reported exhaustion, up to 30 minutes
Physical function
Who could take part
Relapsing MS · 18 to 70
Show the full 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis.BMJ Open · 2020
Background
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.
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History
Started
Apr 2019
Main results due
Feb 2022
Finished
Feb 2022
Results posted
Oct 2023