Department of Global Health, School of Public Health, Peking University, Beijing, China.
Peking University Sixth Hospital (Institute of Mental Health), National Clinical Research Center for Mental Disorders & Key Laboratory of Mental Health, Ministry of Health, Peking University, Beijing, China.
BMJ Open. 2024 Aug 6;14(8):e081122. doi: 10.1136/bmjopen-2023-081122.
Mild cognitive impairment (MCI) is an intermediate phase between normal cognitive ageing and dementia and poses a serious threat to public health worldwide; however, it might be reversible, representing the best opportunity for secondary prevention against serious cognitive impairment. As a non-pharmacological intervention for those patients, interventions that combine physical exercise and cognitive training, whether delivered simultaneously or sequentially, may have superior effects on various cognitive domains, including global cognition, memory, executive function and attention. The supportive evidence remains incomplete. This study aims to assess the effectiveness of a combined exercise and cognitive intervention in Chinese older adults with mild cognitive impairment (COGITO), empowered by digital therapy and guided by the Health Action Process Model and the Theory of Planned Behaviour (HAPA-TPB theory) in a home-based setting.
This study is a randomised controlled, assessor-blinded multi-centre study. Four parallel groups will include a total of 160 patients, receiving either a combined exercise and cognitive intervention, an isolated exercise intervention, an isolated cognitive intervention or only health education. These interventions will be conducted at least twice a week for 50 min each session, over 3 months. All interventions will be delivered at home and remotely monitored through RehabApp and Mini-programme, along with an arm-worn heart rate telemetry device. Specifically, supervisors will receive participants' real-time training diaries, heart rates or other online monitoring data and then provide weekly telephone calls and monthly home visits to encourage participants to complete their tasks and address any difficulties based on their training information. Eligible participants are community-dwelling patients with no regular exercise habit and diagnosed with MCI. The primary outcome is cognitive function assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) and Community Screening Instrument for Dementia (CSI-D), with baseline and three follow-up assessments. Secondary outcomes include quality of life, physical fitness, sleep quality, intrinsic capacity, frailty, social support, adherence, cost-effectiveness and cost-benefit.
The study was approved by the Institutional Review Board of Peking University. Research findings will be presented to stakeholders and published in peer-reviewed journals and at provincial, national and international conferences.
ChiCTR2300073900.
轻度认知障碍（MCI）是正常认知老化与痴呆之间的中间阶段，在全球范围内对公众健康构成严重威胁；然而，它可能是可逆的，是针对严重认知障碍进行二级预防的最佳机会。对于这些患者，将身体锻炼和认知训练相结合的干预措施，无论是同时进行还是先后进行，都可能对各种认知领域（包括整体认知、记忆、执行功能和注意力）产生更好的效果。但现有支持证据并不完整。本研究旨在评估在居家环境中，使用数字疗法，并以健康行动过程模型和计划行为理论（HAPA-TPB 理论）为指导，对中国轻度认知障碍（COGITO）老年患者进行联合运动和认知干预的效果。
这是一项随机对照、评估者盲法、多中心研究。共有 160 名患者将被分为四个平行组，分别接受联合运动和认知干预、单独运动干预、单独认知干预或仅健康教育。这些干预措施将每周至少进行两次，每次 50 分钟，持续 3 个月。所有干预措施都将在家庭中进行，并通过 RehabApp 和小程序以及可穿戴式心率遥测设备进行远程监测。具体来说，主管将接收参与者的实时培训日记、心率或其他在线监测数据，然后根据他们的培训信息每周打电话和每月家访，以鼓励参与者完成任务并解决任何困难。合格的参与者是居住在社区、没有定期运动习惯且被诊断为 MCI 的患者。主要结局是使用阿尔茨海默病评估量表认知部分（ADAS-Cog）和社区痴呆筛查量表（CSI-D）评估认知功能，在基线和三个随访评估时进行。次要结局包括生活质量、身体机能、睡眠质量、内在能力、虚弱、社会支持、依从性、成本效益和成本效益比。
该研究已获得北京大学机构审查委员会的批准。研究结果将提交给利益相关者，并发表在同行评议的期刊上，并在省级、国家和国际会议上发表。
ChiCTR2300073900。
