ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis
Autor: | Amelia K. Boehme, Anne Kever, Seth N Levin, Katherine E Nelson, Joel Stein, Claire S Riley, Victoria M Leavitt, Ines M Aguerre, Nancy W Lee, Rebecca Farber |
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Rok vydání: | 2020 |
Předmět: |
Adult
Male medicine.medical_specialty Multiple Sclerosis Sports medicine Placebo law.invention Randomized controlled trial Double-Blind Method law Oral administration medicine Humans Exercise Aspirin clinical trials sports medicine business.industry Infant General Medicine Institutional review board Test (assessment) Clinical trial Neurology Child Preschool Physical therapy Medicine Female business medicine.drug |
Zdroj: | BMJ Open BMJ Open, Vol 10, Iss 11 (2020) |
ISSN: | 2044-6055 |
Popis: | IntroductionThe many benefits of exercise for persons with multiple sclerosis (MS) are well established, yet patients often refrain from exercise due to overheating and exhaustion. The present randomised controlled trial tests aspirin (acetylsalicylic acid (ASA)) as a convenient method to prevent overheating and improve exercise performance in persons with MS. The effects of ASA are compared with those of acetaminophen (APAP) and placebo.Methods and analysisParticipants are seen for a laboratory maximal exercise test on 3 separate days separated by at least 1 week. At each session, body temperature is measured before oral administration of a standard adult dose (650 mg) of ASA, APAP or placebo. One hour after drug administration, participants perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (that is, time spent cycling to peak exertion) and (b) body temperature change. Crossover analyses will include tests for effects of treatment, period, treatment–period interaction (carryover effect) and sequence.Ethics and disseminationEthical approval was granted by the institutional review board at Columbia University Irving Medical Center (reference: AAAS2529). Results of the trial will be published in peer-reviewed scientific journals and presented at national and international conferences. Neurologists, physiatrists, primary care physicians and physiotherapists are important stakeholders and will be targeted during dissemination. Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.Trial registration numberNCT03824938. |
Databáze: | OpenAIRE |
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