University of Waterloo, 200 University Ave W (BMH 1114), Waterloo, ON, N2L 3G1, Canada.
Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
BMC Geriatr. 2018 Jan 25;18(1):27. doi: 10.1186/s12877-017-0684-0.
Worldwide, almost 50million people lived with dementia in 2016. A cure or disease modifying pharmaceutical treatment for dementia remains elusive so alternative therapies are of critical importance. Mounting evidence supports exercise in the prevention and therapy of dementia. However, the cognitive, physical, and psychological challenges common to dementia along with a poor understanding and accommodation of dementia in the community are major barriers to exercise. Consequently, effective delivery options need to be identified. The primary objective of this study is to compare the effectiveness of center-based (CB) exercise versus home-based (HB) exercise for achievement of physical activity guidelines among people with MCI or mild dementia.
This is a randomized parallel-group trial comparing the effects of CB and HB exercise adherence among community-dwelling adults ≥50 years with a clinical diagnosis of MCI or mild dementia. Participants will be randomized to either CB or HB exercise. The CB group will meet weekly for small group exercise and will be prescribed additional exercise to be completed independently. Participants in the HB group will be given a physical activity prescription to be completed independently in the community. Participants in HB will also be contacted by phone monthly to adjust exercise prescriptions. The primary outcome will be achievement of exercise guidelines (150 min/wk. of moderate activity) assessed using an activity monitor. Secondary objectives will evaluate cost-effectiveness and the influence of individual and environmental factors on the primary outcome. Tertiary outcomes include physical function, cognition, mood, and quality of life.
There is scant research to indicate the most effective way to deliver exercise to people with MCI and mild dementia, which is needed specifically because these groups face significant barriers to exercise. To capitalize on the benefits of exercise, feasible exercise delivery options need to be identified. The results of this study will directly complement ongoing clinical trials and will be essential to implementing exercise recommendations specific to the prevention and therapy of dementia in a feasible and cost-effective manner when they emerge.
Clinicatrials.gov ; Identifier: NCT02774720 (version updated December 12, 2016).
2016 年，全球约有 5000 万人患有痴呆症。对于痴呆症，仍然缺乏治愈或能够改变疾病进程的药物治疗方法，因此替代疗法至关重要。越来越多的证据支持锻炼可预防和治疗痴呆症。然而，痴呆症患者通常存在认知、身体和心理方面的挑战，加上社区对痴呆症的认识和适应不足，这些都是锻炼的主要障碍。因此，需要确定有效的实施方式。本研究的主要目的是比较基于中心（CB）的运动与基于家庭（HB）的运动对认知障碍或轻度痴呆症患者实现身体活动指南的效果。
这是一项随机平行组试验，比较了社区居住的≥50 岁成年人中基于中心和基于家庭的运动对认知障碍或轻度痴呆症患者的运动依从性的影响。参与者将被随机分配到 CB 或 HB 运动组。CB 组将每周进行小组运动，此外还将规定额外的独立运动。HB 组的参与者将获得一份在社区内完成的身体活动处方。HB 组的参与者还将每月通过电话联系以调整运动处方。主要结局是使用活动监测器评估达到运动指南（每周 150 分钟的中等强度活动）的情况。次要目标将评估成本效益以及个体和环境因素对主要结局的影响。次要结局包括身体机能、认知、情绪和生活质量。
几乎没有研究表明向认知障碍或轻度痴呆症患者提供运动的最有效方法，这是因为这些人群面临着锻炼的重大障碍。为了利用锻炼的益处，需要确定可行的锻炼实施方式。本研究的结果将直接补充正在进行的临床试验，并且在出现具体针对痴呆症预防和治疗的运动建议时，对于以可行和具有成本效益的方式实施这些建议至关重要。
Clinicatrials.gov；标识符：NCT02774720（2016 年 12 月 12 日更新版本）。
