Author Of 1 Presentation
P0190 - ASPIRE Study: Protocol for a double-blind RCT of aspirin for overheating during exercise in MS (ID 666)
Abstract
Background
Background Exercise holds many benefits for persons with multiple sclerosis (MS), yet many MS patients are heat sensitive and therefore avoid exercise due to overheating and exhaustion that result. The exercise literature in MS to date is likely subject to bias by predominant representation of patients who are not heat sensitive and may not be a representative sample. Finding ways to facilitate comfortable engagement in exercise for persons with MS is a key priority. Our pilot trial of aspirin as a cooling pretreatment for exercise in MS showed favorable results: after aspirin, participants who experience overheating during exercise were able to exercise longer and the amount of body temperature increase they experienced was reduced by 56%.
Objectives
Objective Conduct a large-scale double-blind randomized controlled trial of aspirin (acetylsalicylic acid, ASA) pretreatment as a convenient and inexpensive method to prevent overheating and improve exercise performance in persons with MS, compared to placebo and acetaminophen.
Methods
Methods Participants are seen for three separate sessions (separated by at least one week) for a laboratory maximal exercise test. At each session, body temperature is measured tympanically before oral administration of a standard adult dose (650 mg) of aspirin, acetaminophen (APAP), or placebo. Participants then perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (TTE, i.e., time spent cycling to peak exertion) and (b) body temperature change. Secondary outcomes include patient reported outcomes including pain, fatigue, and mood. Cross-over analyses will include tests for effects of treatment, period, treatment–period interaction (carryover effect) and sequence.
Results
Results Enrollment in the ASPIRE trial was begun in February 2019. Adherence and acceptability of the treatment are high. To date, 35 participants have been enrolled; of these, 16 have completed all 3 study visits. There have been 6 drop-outs and 7 non-serious adverse events. Heterogeneity of sample is notable, with 26% men, 9% Black, 6% Hispanic/Latinx. Study data will not be unblinded until completion of all participants (target N=60).
Conclusions
Conclusions Exercise is highly beneficial for persons with MS, but only if they do it. Positive findings from this trial would yield an effective, inexpensive, readily available, unobtrusive treatment to allow many more persons with MS access to the benefits of exercise via a cooling mechanism. Thus far, enrollment and adherence in the ASPIRE trial, as well as diversity of our sample suggest good acceptibiliity of aspirin as a treatment, and favorable generalizability of trial results.