老年多发性硬化症患者的力量训练对神经变性、神经肌肉功能和身体功能的影响。老年多发性硬化症患者力量训练(PoTOMS)随机对照试验 "研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-02-19 DOI:10.1016/j.conctc.2024.101279
Tobias Gaemelke , Christoffer Laustsen , Peter Feys , Lars Folkestad , Marianne Skovsager Andersen , Niklas Rye Jørgensen , Marie-Louise Jørgensen , Sune Nørhøj Jespersen , Steffen Ringgaard , Simon F. Eskildsen , Ulrik Dalgas , Lars G. Hvid
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引用次数: 0

摘要

导言:在所有多发性硬化症患者(pwMS)中,约有三分之一是老年人,即年龄≥60 岁。虽然老龄化和多发性硬化症会分别对大脑形态、神经肌肉功能和身体机能产生恶化影响,但老龄化和多发性硬化症的结合可能会带来特别的挑战。为了抵消这种不利的变化,力量训练(即一种阻力运动,侧重于在最大预期运动速度下的中高负荷)是一种可行且高效的解决方案。众所周知,力量训练对身体机能、神经肌肉功能以及大脑形态都有积极影响。现有的证据很有希望,但仅限于中青年多发性硬化症患者,对老年多发性硬化症患者进行力量训练的效果仍有待阐明。该试验比较了 24 周常规护理(30 人)与 24 周常规护理和力量训练(30 人)。主要结果是全脑萎缩率。次要结果包括大脑微观和宏观结构、神经肌肉功能、身体功能、认知功能、骨骼健康和患者报告结果的变化。伦理和传播本研究已获得地区伦理委员会批准(参考编号 1-10-72-222-20),并在丹麦数据保护局注册(参考编号 2016-051-000001)。所有研究结果都将在同行评审的科学期刊上发表,并在相关科学会议上进行独立展示。www.clinicaltrials.gov 识别码为 NCT04762342。
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Effects of power training in older patients with multiple sclerosis on neurodegeneration, neuromuscular function, and physical function. A study protocol for the “power training in older multiple sclerosis patients (PoTOMS) randomized control trial

Introduction

Approximately one-third of all persons with multiple sclerosis (pwMS) are older, i.e., having an age ≥60 years. Whilst ageing and MS separately elicit deteriorating effects on brain morphology, neuromuscular function, and physical function, the combination of ageing and MS may pose a particular challenge. To counteract such detrimental changes, power training (i.e., a type of resistance exercise focusing on moderate-to-high loading at maximal intended movement velocity) presents itself as a viable and highly effective solution. Power training is known to positively impact physical function, neuromuscular function, as well as brain morphology. Existing evidence is promising but limited to young and middle-aged pwMS, with the effects of power training remaining to be elucidated in older pwMS.

Methods

The presented ‘Power Training in Older MS patients (PoTOMS)’ trial is a national, multi-center, parallel-group, randomized controlled trial. The trial compares 24 weeks of usual care(n = 30) to 24 weeks of usual care and power training (n = 30). The primary outcome is whole brain atrophy rate. The secondary outcomes include changes in brain micro and macro structures, neuromuscular function, physical function, cognitive function, bone health, and patient-reported outcomes.

Ethics and dissemination

The presented study is approved by The Regional Ethics Committee (reference number 1-10-72-222-20) and registered at the Danish Data Protection Agency (reference number 2016-051-000001). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences independent of the results. The www.clinicaltrials.gov identifier is NCT04762342.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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