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Aspirin as a Pre-Treatment for Exercise in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051646
Recruitment Status : Completed
First Posted : February 14, 2017
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Victoria M. Leavitt, Columbia University

Brief 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).


Condition or disease Intervention/treatment Phase
Fatigue Overheating Drug: Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit Drug: Placebo at 1st visit, then Acetylsalicylic acid at 2nd visit Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Design is a within-subject crossover placebo-controlled experiment. Each participant will be seen for two exercise sessions (stationary cycling) on two days separated by one week, and will receive either ASA or placebo (treatment) at each session prior to commencing exercise. Order of treatment will be randomized and counter-balanced. As such, each participant will serve as his/her own control.
Masking: Double (Participant, Investigator)
Masking Description: Blinding will be overseen by the CUMC pharmacy; randomization schedule will be submitted to the pharmacy by a third party who is not involved in the study (i.e., non-study personnel). Study investigators will remain blinded until data collection is complete and data have been analyzed.
Primary Purpose: Treatment
Official Title: A Placebo-controlled Double Blind Crossover Trial of Acetylsalicylic Acid as a Pre-treatment for Exercise in Multiple Sclerosis
Actual Study Start Date : January 13, 2017
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : May 10, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Acetylsalicylic acid first, placebo second
Participant is administered acetylsalicylic acid one hour prior to exercise.
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
Other Names:
  • aspirin
  • placebo

Placebo Comparator: Placebo oral capsule first, ASA second
Participant is administered placebo 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
Other Names:
  • placebo
  • aspirin




Primary Outcome Measures :
  1. Change in Time to Exhaustion [ Time Frame: ASA's effect will be assessed from date of randomization until cessation of exercise test at each of two study visits to be completed within a 14-day period. ]
    The measure of interest is the length of time (in seconds) spent exercising at each session. This time has no pre-set upper limit, i.e. patients are free to exercise as long as they wish. This means that the time will not be censored. However, please note that healthy adults' time to exhaustion is approximately 12 minutes.


Secondary Outcome Measures :
  1. Exercise-induced Body Temperature Increase [ Time Frame: Effect of treatment on body temperature in a single session (i.e., pre- to post- exercise test) to be completed within a 14-day period ]
    Measure of interest is increase in body temperature from pre- to post-exercise test in each treatment condition (ASA vs. placebo)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RRMS
  • self report of overheating during exercise
  • low physical disability (EDSS total score 4.5 or less); fully ambulatory without aid
  • exacerbation-free (and no use of corticosteroids) for 6 weeks prior
  • BMI 35 or lower

Exclusion Criteria:

  • uncontrolled hypertension or vascular disease of the legs
  • current medications for heart or blood pressure problem
  • prior history of head injury, stroke, or other neurological disease/disorder
  • currently taking antipyretics or pain medication daily
  • presence of major depressive disorder or other psychiatric diagnosis
  • formally diagnosed sleep disorder
  • pulmonary disease, heart disease or other heart problem
  • diabetes mellitus or problem with blood sugar levels
  • lower body weakness or reliance on supportive devices for walking (as indicated through EDSS)
  • counter indications to aspirin use: history of confirmed peptic ulcer, gastrointestinal or sever gynecological bleeding; tarry stool or fecal occult blood; syndrome of asthma, rhinitis or nasal polyps

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051646


Locations
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United States, New York
Columbia University Medical Center, MS Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Victoria Leavitt, PhD Assistant Professor of Neuropsychology
  Study Documents (Full-Text)

Documents provided by Victoria M. Leavitt, Columbia University:
Informed Consent Form  [PDF] December 29, 2016


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Responsible Party: Victoria M. Leavitt, Assistant Professor of Neuropsychology, Columbia University
ClinicalTrials.gov Identifier: NCT03051646    
Other Study ID Numbers: AAAQ1758
First Posted: February 14, 2017    Key Record Dates
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Victoria M. Leavitt, Columbia University:
Exercise
Time to Exhaustion
Additional relevant MeSH terms:
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Multiple Sclerosis
Fatigue
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics