Karssemeijer E G A, Bossers W J R, Aaronson J A, Kessels R P C, Olde Rikkert M G M
Department of Geriatric Medicine, Donders Institute for Brain Cognition and Behaviour, Radboud university medical center, Nijmegen, The Netherlands.
Radboud university medical center, Radboudumc Alzheimer Center, PO 9101 (hp 925), Nijmegen, 6500 HB, The Netherlands.
BMC Geriatr. 2017 Mar 21;17(1):73. doi: 10.1186/s12877-017-0464-x.
To date there is no cure or an effective disease-modifying drug to treat dementia. Available acetylcholine-esterase inhibiting drugs or memantine only produce small benefits on cognitive and behavioural functioning and their clinical relevance remains controversial. Combined cognitive-aerobic interventions are an appealing alternative or add-on to current pharmacological treatments. The primary aim of this study is to investigate the efficacy of a combined cognitive-aerobic training and a single aerobic training compared to an active control group in older adults with mild dementia. We expect to find a beneficial effect on executive functioning in both training regimes, compared to the control intervention, with the largest effect in the combined cognitive-aerobic group. Secondary, intervention effects on cognitive functioning in other domains, physical functioning, physical activity levels, activities of daily living, frailty and quality of life are studied.
The design is a single-blind, randomized controlled trial (RCT) with three groups: a combined cognitive-aerobic bicycle training (interactive cycling), a single aerobic bicycle training and a control intervention, which consists of stretching and toning exercises. Older adults with mild dementia follow a 12-week training program consisting of three training sessions of 30-40 min per week. The primary study outcome is objective executive functioning measured with a neuropsychological assessment. Secondary measures are objective cognitive functioning in other domains, physical functioning, physical activity levels, activities of daily living, frailty, mood and quality of life. The three groups are compared at baseline, after 6 and 12 weeks of training, and at 24-week follow-up.
This study will provide novel information on the effects of an interactive cycling training on executive function in older adults with mild dementia. Furthermore, since this study has both a combined cognitive-aerobic training and a single aerobic training group the effectiveness of the different components of the intervention can be identified. The results of this study may be used for physical and mental activity recommendations in older adults with dementia.
The Netherlands National Trial Register NTR5581 . Registered 14 February 2016.
迄今为止，尚无治愈或有效改善疾病的药物来治疗痴呆症。现有的乙酰胆碱酯酶抑制药物或美金刚仅对认知和行为功能产生微小益处，其临床相关性仍存在争议。联合认知-有氧运动干预是当前药物治疗的一种有吸引力的替代方案或补充。本研究的主要目的是调查与积极对照组相比，联合认知-有氧运动训练和单一有氧运动训练对轻度痴呆老年人的疗效。我们预计，与对照干预相比，两种训练方案对执行功能均有有益影响，联合认知-有氧运动组的效果最为显著。其次，研究干预对其他领域认知功能、身体功能、身体活动水平、日常生活活动、衰弱和生活质量的影响。
本研究设计为单盲随机对照试验（RCT），分为三组：联合认知-有氧运动自行车训练（交互式骑行）、单一有氧运动自行车训练和对照干预，对照干预包括伸展和塑形运动。轻度痴呆的老年人参加为期12周的训练计划，每周进行三次30-40分钟的训练课程。主要研究结果是通过神经心理学评估测量的客观执行功能。次要指标包括其他领域的客观认知功能、身体功能、身体活动水平、日常生活活动能力、衰弱、情绪和生活质量。在基线、训练6周和12周后以及24周随访时对三组进行比较。
本研究将提供关于交互式骑行训练对轻度痴呆老年人执行功能影响的新信息。此外，由于本研究既有联合认知-有氧运动训练组又有单一有氧运动训练组，因此可以确定干预不同组成部分的有效性。本研究结果可用于为痴呆老年人提供身心活动建议。
荷兰国家试验注册NTR5581。2016年2月14日注册。
