Rationale and Design of the PARTNER Trial: Partnered Rhythmic Rehabilitation for Enhanced Motor-Cognition in Prodromal Alzheimer's Disease.
Rationale and Design of the PARTNER Trial: Partnered Rhythmic Rehabilitation for Enhanced Motor-Cognition in Prodromal Alzheimer's Disease.
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DOI：
10.3233/jad-220783
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发表时间：
2023
影响因子：
4
通讯作者：
Hackney, Madeleine E.
中科院分区：
文献类型：
--
作者：
Cao, Ke;Bay, Allison A.;Hajjar, Ihab;Wharton, Whitney;Goldstein, Felicia;Qiu, Deqiang;Prusin, Todd;McKay, J. Lucas;Perkins, Molly M.;Hackney, Madeleine E.
阿尔茨海默病（AD）的功能下降受到整合和调节复杂认知和运动能力（通常称为运动认知整合）能力受损的影响。运动认知整合受损发生在AD的早期阶段，前驱AD（pAD），并且可能先于其他症状。结合运动和认知训练已被推荐用于pAD患者，需要更好地研究。我们的数据表明，合作节奏康复（PRR）改善运动认知整合的老年人认知障碍。PRR是同时针对对AD重要的心血管、社会和运动认知领域的理想干预。我们计划在66例pAD患者中开展一项为期1年的II期、单盲、随机对照试验，使用PRR。参与者将被分配到三个月的双周会议，然后是九个月的每周会议的PRR或集体步行（步行）与1：1的分配。对照组的集体步行将使我们能够比较单独的体育锻炼与PRR认知参与元素的额外益处。使用意向治疗方法，这项创新的初步研究将1）确定PRR的可接受性、安全性、耐受性和满意度; 2）比较PRR与WALK改善运动-认知整合的疗效，并从一组运动-认知、体积MRI和认知测量中确定III期试验的最敏感终点。本研究还将探索PRR影响pAD的潜在神经、血管和炎症机制，以得出这些中间指标的效应量，并帮助我们估计未来试验的样本量。
Functional decline in Alzheimer’s disease (AD) is impacted by impaired ability to integrate and modulate complex cognitive and motor abilities, commonly known as motor-cognitive integration. Impaired motor-cognitive integration occurs in the early stages of AD, prodromal AD (pAD), and may precede other symptoms. Combined motor and cognitive training have been recommended for people with pAD and need to be better researched. Our data suggest that partnered rhythmic rehabilitation (PRR) improves motor-cognitive integration in older adults with cognitive impairment. PRR is an ideal intervention to simultaneously target cardiovascular, social, and motor-cognitive domains important to AD. We propose to conduct a 1-year Phase II, single-blind randomized controlled trial using PRR in 66 patients with pAD. Participants will be assigned to three months of biweekly sessions, followed by nine months of weekly sessions of PRR or group walking (WALK) with 1 : 1 allocation. Group walking in the control group will allow us to compare physical exercise alone versus the added benefit of the cognitively engaging elements of PRR. Using an intent-to-treat approach, this innovative pilot study will 1) Determine acceptability, safety, tolerability, and satisfaction with PRR; 2) Compare efficacy of PRR versus WALK for improving motor-cognitive integration and identify the most sensitive endpoint for a Phase III trial from a set of motor-cognitive, volumetric MRI, and cognitive measures. The study will additionally explore potential neural, vascular, and inflammatory mechanisms by which PRR affects pAD to derive effect size of these intermediary measures and aid us in estimating sample size for a future trial.