背景:卒中增加了随后的痴呆风险,但没有特定的卒中后疗法来保护认知。建议心肺运动用于中风的二级预防,可能具有神经保护作用。缺血性卒中后心血管运动研究(PISCES)旨在减少卒中后继发性神经变性和认知功能下降。大流行期间,我们转向了ZOom提供的认知衰退干预(ZODIAC)方案,减少大流行放大的锻炼障碍。
方法:我们介绍了一项针对缺血性卒中幸存者的多中心IIb期评估盲法随机对照试验的大流行适应,该试验测试了卒中后2个月进行的为期8周的家庭运动干预的有效性和可行性。我们比较心肺运动(干预臂)与平衡和伸展(主动控制臂)。参与者通过磁共振成像(MRI)进行评估,健身,血,微生物组,和神经心理学测试在三个研究访问:运动干预前后和12个月。对原始协议的修改包括运动前安全家访,商业交付锻炼设备,以方便评估员失明,并重新考虑统计计划,以允许汇集研究。我们将面对面的研究访问从27次减少到3次。主要结果仍然是组间(干预与对照组)脑容量变化的差异;次要结果是组间整体认知能力的差异,以允许对经过验证的认知量表进行远程管理。
结论:远程提供的运动干预可以减轻参与者的负担,并可能减少招募障碍。通过自我报告的问卷和电话调查获得更多的信息,可以支持面对面研究访问次数的减少。
背景:前瞻性ACTRN12616000942459。2016年7月注册
BACKGROUND: Stroke increases subsequent dementia risk yet there are no specific post-stroke therapies to protect cognition. Cardiorespiratory exercise is recommended for secondary prevention of stroke and may be neuroprotective. The Post Ischaemic Stroke Cardiovascular Exercise
Study (PISCES) aims to reduce post-stroke secondary neurodegeneration and cognitive decline. During the pandemic, we pivoted to a ZOom Delivered Intervention Against Cognitive decline (ZODIAC) protocol, reducing pandemic-amplified barriers to exercise.
METHODS: We present pandemic adaptions for a multicentre phase IIb assessor-blinded randomised controlled
trial of ischaemic stroke survivors testing the efficacy and feasibility of an 8-week home-based exercise intervention delivered at 2 months post-stroke. We compare cardiorespiratory exercise (intervention arm) versus balance and stretching (active control arm). Participants are assessed with magnetic resonance imaging (MRI), fitness, blood, microbiome, and neuropsychological tests at three
study visits: before and after the exercise intervention and at 12 months. Modifications to the original protocol include pre-exercise safety home visits, commercial delivery of exercise equipment to facilitate assessor blinding, and reconsideration of statistical plan to allow pooling of the studies. We have reduced in-person
study visits from 27 to 3. Primary outcome remains between-group (intervention versus control) difference in brain volume change; secondary outcome is between-group difference in global cognitive ability to allow remote administration of a validated cognitive scale.
CONCLUSIONS: Remotely delivered exercise interventions reduce participant burden and may reduce barriers to recruitment. A decrease in the number of in-person
study visits can be supported by greater information capture via self-reported questionnaires and phone surveys.
BACKGROUND: Prospectively ACTRN12616000942459. Registered on July 2016.