ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis.

ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis.
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DOI:
10.1136/bmjopen-2020-039691
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发表时间:
2020-11-14
期刊:
影响因子:
2.9
通讯作者:
Leavitt VM
Leavitt VM
中科院分区:
医学3区
文献类型:
--
作者:
Kever A;Nelson KE;Aguerre IM;Riley CS;Boehme A;Lee NW;Strauss Farber R;Levin SN;Stein J;Leavitt VM

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运动对多发性硬化症(MS)患者的许多好处已经得到了充分的证实,但患者往往由于过热和疲惫而不运动。本随机对照试验测试阿司匹林(乙酰水杨酸(ASA))作为一种方便的方法,以防止过热和提高运动能力的人与MS。ASA的效果进行了比较,对乙酰氨基酚(APAP)和安慰剂。在间隔至少1周的3个单独的日子观察参与者进行实验室最大运动测试。在每次治疗中,在口服标准成人剂量(650 mg)ASA、APAP或安慰剂之前测量体温。给药后1小时,参与者在自行车测力计上进行最大斜坡测试。主要结果是(a)至力竭的时间(即,骑自行车达到最大消耗所花费的时间)和(B)体温变化。交叉分析将包括治疗效应、阶段、治疗-阶段相互作用(遗留效应)和序列的检验。伦理批准由哥伦比亚大学欧文医学中心的机构审查委员会授予(参考:AAAS 2529)。试验结果将发表在同行评审的科学期刊上,并在国家和国际会议上发表。神经科医生、理疗师、初级保健医生和理疗师是重要的利益攸关方,在传播过程中将以他们为目标。积极的试验结果有可能促进阿司匹林治疗,这是一种廉价且容易获得的治疗方法,可以减少过热,并让更多的MS患者从运动中受益。NCT 03824938。
The 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. Participants 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. Ethical 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. NCT03824938.
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