Aspirin as a Pre-Treatment for Exercise in Multiple Sclerosis

Summary

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).

Conditions

• Fatigue
• Overheating

Interventions

DRUG

Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit

650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise; Placebo oral capsule is administered one hour prior to exercise

DRUG

Placebo at 1st visit, then Acetylsalicylic acid at 2nd visit

Placebo oral capsule is administered one hour prior to exercise; 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise

Sponsors & Collaborators

• National Multiple Sclerosis Society

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Victoria Leavitt, PhD · Assistant Professor of Neuropsychology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-13

Primary Completion

2017-05-10

Completion

2017-05-10

FDA Drug

Yes

Countries

• United States

Study Locations