Aspirin for Exercise in Multiple Sclerosis (ASPIRE) (ASPIRE)

October 4, 2023 updated by: Victoria M. Leavitt, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirin
Aspirin 650 mg capsule by mouth, single dose
Drug: Aspirin 650mg Oral Capsule
A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Other Names:
  • Aspirin
Active Comparator: Acetaminophen
Acetaminophen 650 mg capsule by mouth, single dose
Drug: Acetaminophen Tablet 650mg
A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Other Names:
  • Acetaminophen
Placebo Comparator: Placebo
Placebo 650 mg capsule by mouth, single dose
Other: Placebo
A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from start of exercise test until self-reported exhaustion, up to 30 minutes
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.
from start of exercise test until self-reported exhaustion, up to 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise-induced body temperature increase
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
from start of exercise test until self-reported exhaustion, up to 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

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

Investigators

  • Principal Investigator: Victoria M Leavitt, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAS2529
  • 1R21HD091836-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw data for primary and secondary outcomes will be shared with qualified researchers upon reasonable request to study PI.

IPD Sharing Time Frame

Data will be available from close of the study until 2031.

IPD Sharing Access Criteria

Qualified researchers, upon request to study PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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