Trautwein Sandra, Scharpf Andrea, Barisch-Fritz Bettina, Niermann Christina, Woll Alexander
Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.
JMIR Res Protoc. 2017 Mar 3;6(3):e35. doi: 10.2196/resprot.6792.
The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking.
This study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high-quality multicenter trial.
A multicenter randomized controlled trial with baseline and postassessments will be performed. It is planned to enroll 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-week ritualized MEP especially developed for IWD. The effectiveness of the MEP on the primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limbs, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, and visual spatial cognition).
Enrollment for the study started in May 2015. It is planned to complete postassessments by the beginning of 2017. Results are expected to be available in the first half of 2017.
This study will contribute to enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterized by a dementia-specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant to influence the multiple motor and cognitive impairments of IWD who are often participating in limited physical activity.
German Clinical Trials Register DRKS00010538; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010538 (Archived by WebCite at http://www.webcitation.org/6oVGMbbMD).
在未来几十年里，痴呆症患病率不断上升，随之而来的是各种社会和经济问题。先前的研究表明，体育活动对痴呆症患者（IWD）的运动和认知技能有积极影响。然而，可能由于一些方法学上的局限性，证据并不充分。此外，迄今为止，还缺乏专门为IWD制定的适当体育活动干预措施。
本研究旨在通过一项高质量的多中心试验，调查多模式运动计划（MEP）对IWD运动和认知技能的有效性。
将进行一项有基线评估和后评估的多中心随机对照试验。计划招募405名年龄在65岁及以上的轻至中度痴呆症患者。干预组将参加一项专门为IWD制定的为期16周的规范化MEP。将使用一套综合测试来检查MEP对主要结局平衡、 mobility和步态的有效性。次要结局包括下肢力量和功能、日常生活活动能力以及认知（整体认知、语言、处理速度、学习和记忆以及视觉空间认知）。
该研究于2015年5月开始招募。计划在2017年初完成后评估。预计结果将于2017年上半年公布。
本研究将有助于增强体育活动对IWD运动和认知技能影响的证据。与先前的研究相比，本研究的特点是基于科学知识的针对痴呆症的干预、干预中运动和认知任务的结合以及方法学上的高标准。研究结果对于影响经常参与有限体育活动的IWD的多种运动和认知障碍具有高度相关性。
德国临床试验注册中心DRKS00010538；https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010538（由WebCite存档于http://www.webcitation.org/6oVGMbbMD）
