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Completed

NCT Number: NCT03824938

Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aspirin 650mg Oral Capsule

Drug

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

Other names: Aspirin

Acetaminophen Tablet 650mg

Drug

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

Other names: Acetaminophen

Placebo

Other

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

Primary outcomes

  1. Time-to-exhaustion

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

    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.

  2. Exercise-induced Body Temperature Change

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

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)

Acronym: ASPIRE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2019
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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