Aspirin as a Pre-Treatment for Exercise in Multiple Sclerosis
A Placebo-controlled Double Blind Crossover Trial of Acetylsalicylic Acid as a Pre-treatment for Exercise in Multiple Sclerosis
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
Placebo
- Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit
- Placebo at 1st visit, then Acetylsalicylic acid at 2nd visit
Results by group
Change in Time to Exhaustion
ASA's effect will be assessed from date of randomization until cessation of exercise test at each of two study visits to be completed within a 14-day period.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Acetylsalicylic Acid | 568 seconds | 150 (Standard Deviation) | 12 |
| Placebo Oral Capsule | 552 seconds | 152 (Standard Deviation) | 12 |
Acetylsalicylic Acid
Placebo Oral Capsule
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Acetylsalicylic Acid | 12 | 0 (0.0%) | 0 |
| Placebo Oral Capsule | 12 | 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
Change in Time to Exhaustion
ASA's effect will be assessed from date of randomization until cessation of exercise test at each of two study visits to be completed within a 14-day period.
Physical function
Other measures (1)
Exercise-induced Body Temperature Increase
Effect of treatment on body temperature in a single session (i.e., pre- to post- exercise test) to be completed within a 14-day period
Physical function
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
* RRMS * self report of overheating during exercise * low physical disability (EDSS total score 4.5 or less); fully ambulatory without aid * exacerbation-free (and no use of corticosteroids) for 6 weeks prior * BMI 35 or lower
Exclusion criteria
* uncontrolled hypertension or vascular disease of the legs * current medications for heart or blood pressure problem * prior history of head injury, stroke, or other neurological disease/disorder * currently taking antipyretics or pain medication daily * presence of major depressive disorder or other psychiatric diagnosis * formally diagnosed sleep disorder * pulmonary disease, heart disease or other heart problem * diabetes mellitus or problem with blood sugar levels * lower body weakness or reliance on supportive devices for walking (as indicated through EDSS) * counter indications to aspirin use: history of confirmed peptic ulcer, gastrointestinal or sever gynecological bleeding; tarry stool or fecal occult blood; syndrome of asthma, rhinitis or nasal polyps
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Exercise has many benefits for people with multiple sclerosis (MS), such as improved physical symptoms, mood, fatigue, and cognition. However, many people with MS refrain from exercising because of the discomfort of exhaustion and overheating that they experience. This study investigates the use of aspirin before exercise as a treatment to reduce overheating and exhaustion, thereby availing many more people with MS the opportunity to benefit from exercise. The investigators recently published the first-ever report of elevated body temperature in relapsing-remitting MS (RRMS) patients relative to healthy controls, and elevated temperature was linked to worse fatigue. This finding that body temperature is elevated and linked to fatigue in RRMS lays the groundwork for a paradigm shift in our understanding and treatment of fatigue. That is, the focus shifts from exogenous to endogenous temperature, and from stimulant medication to cooling treatments. A recent study comparing healthy adults to adults with MS showed that whereas exercise increased body temperature in both groups, only in the MS group was it correlated with exhaustion. The reason for this may relate to the elevation in resting body temperature in relapsing-remitting MS (RRMS) patients relative to healthy controls. The finding is clinically meaningful, as elevated body temperature was correlated with worse fatigue in patients. Exercise Aim: To determine whether pretreatment with ASA (compared to placebo: within subject crossover design) before exercise results in improved exercise performance (i.e., increased time-to-exhaustion). The investigators hypothesize that participants will tolerate exercise for longer after taking ASA than placebo. This hypothesis is based on a) demonstrated efficacy of antipyretic for reducing body temperature during exercise in healthy controls, b) demonstrated efficacy of antipyretic for reducing fatigue in non-exercising MS patients, and c) demonstrated efficacy of elaborate (unblinded) cooling treatments (e.g., cooling garments, cooling hand chamber) for improving exercise performance in MS patients. Note that this project is especially important for MS patients, who have a disease-specific body temperature elevation and sensitivity to heat (i.e., Uhthoff's).
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History
Started
Jan 2017
Main results due
May 2017
Finished
May 2017
Results posted
Nov 2018