Makizako Hyuma, Tsutsumimoto Kota, Doi Takehiko, Hotta Ryo, Nakakubo Sho, Liu-Ambrose Teresa, Shimada Hiroyuki
Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, 7-430 Morioka-cho, Obu, Aichi, 474-8551, Japan.
Japan Society for the Promotion of Science, Kojimachi Business Center Building, 5-3-1 Kojimachi, Chiyoda-ku, Tokyo, 102-0083, Japan.
Trials. 2015 Nov 4;16:499. doi: 10.1186/s13063-015-1032-3.
Depressive symptoms and memory problems are significant risk factors for dementia. Exercise can reduce depressive symptoms and improve cognitive function in older people. In addition, the benefits of horticultural activity on physical and mental well-being have been demonstrated in people with dementia. Although evidence of such non-pharmacological interventions is mounting, no studies have examined whether physical exercise and horticultural activity exert a positive impact on brain and mental health (e.g., depressive symptoms) in non-demented older adults at high risk of cognitive impairment and depression. Therefore, we propose a randomized controlled trial to assess the efficacy and efficiency of physical exercise and horticultural activity in improving brain and mental health in community-dwelling older adults with memory problems and depressive symptoms.
METHODS/DESIGN: The 20-week randomized controlled trial will include 90 community-dwelling adults aged 65 years or older with memory problems and depressive symptoms. Participants will be randomized to one of three experiments: exercise, horticultural activity, or educational control group, using a 1:1:1 allocation ratio. The combined exercise program and horticultural activity program will consist of 20 weekly 90-minute sessions. Participants in the exercise group will practice aerobic exercise, muscle strength training, postural balance retraining, and dual-task training. The horticultural activity program will include crop-related activities, such as field cultivation, growing, and harvesting. Participants in the educational control group will attend two 90-minute educational classes during the 6-month trial period. Depressive symptoms and memory performance will be measured by the Geriatric Depression Scale-15, and the Logical Memory subtests of the Wechsler Memory Scale-Revised will be used to measure depressive symptoms and memory performance as primary outcomes, at baseline (prior to randomization), immediately following intervention (6 months from baseline), and 6 months after intervention. Hippocampal volume will be measured at baseline and immediately after intervention, using magnetic resonance imaging. Secondary outcomes will comprise cognitive function, including language, attention/executive performance, and processing speed; brain-derived neurotrophic-factor serum levels; and health-related quality of life.
This intervention study will determine the clinical importance and efficacy of physical exercise and horticultural activity as non-pharmacological interventions in community-dwelling older adults at high risk of poor brain and mental health.
UMIN000018547 ; registered 7 August 2015.
抑郁症状和记忆问题是痴呆症的重要风险因素。运动可以减轻老年人的抑郁症状并改善认知功能。此外，园艺活动对痴呆症患者身心健康的益处已得到证实。尽管此类非药物干预的证据越来越多，但尚无研究探讨体育锻炼和园艺活动对有认知障碍和抑郁高风险的非痴呆老年人的大脑和心理健康（如抑郁症状）是否有积极影响。因此，我们提议进行一项随机对照试验，以评估体育锻炼和园艺活动对有记忆问题和抑郁症状的社区老年人改善大脑和心理健康的疗效和效果。
方法/设计：这项为期20周的随机对照试验将纳入90名65岁及以上有记忆问题和抑郁症状的社区成年人。参与者将以1:1:1的分配比例随机分为三个试验组之一：运动组、园艺活动组或教育对照组。运动和园艺活动联合项目将包括每周20次，每次90分钟的课程。运动组的参与者将进行有氧运动、肌肉力量训练、姿势平衡再训练和双任务训练。园艺活动项目将包括与作物相关的活动，如田间种植、生长和收获。教育对照组的参与者将在为期6个月的试验期间参加两次90分钟的教育课程。抑郁症状和记忆表现将通过老年抑郁量表-15进行测量，韦氏记忆量表修订版的逻辑记忆子测试将用于在基线（随机分组前）、干预后立即（基线后6个月）和干预后6个月测量抑郁症状和记忆表现作为主要结局。海马体积将在基线和干预后立即使用磁共振成像进行测量。次要结局将包括认知功能，包括语言、注意力/执行能力和处理速度；脑源性神经营养因子血清水平；以及与健康相关的生活质量。
这项干预研究将确定体育锻炼和园艺活动作为非药物干预措施对有大脑和心理健康不佳高风险的社区老年人的临床重要性和疗效。
UMIN000018547；于2015年8月7日注册。
