Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

Columbia University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Aspirin 650mg Oral CapsuleDRUG

A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.

Acetaminophen Tablet 650mgDRUG

A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.

PlaceboOTHER

A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Time-to-exhaustion

Duration of time exercising before reaching peak exertion, defined as cadence drop below 40 revolutions per minute (RPM) for \>/= 5 seconds, or patient reaches volitional exhaustion in accordance with American Thoracic Society standard test termination criteria.

Time frame: from start of exercise test until self-reported exhaustion, up to 30 minutes

Exercise-induced Body Temperature Change

Change in body temperature from pre- to post- maximal exercise test.

Time frame: from start of exercise test until self-reported exhaustion, up to 30 minutes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.