背景:轻度认知障碍(MCI)是介于正常认知老化和痴呆之间的中间阶段,对全球公共卫生构成严重威胁;它可能是可逆的,代表二级预防严重认知障碍的最佳机会。作为对这些患者的非药物干预,结合体育锻炼和认知训练的干预措施,无论是同时交付还是顺序交付,可能对各种认知领域有优越的影响,包括全球认知,记忆,执行功能和注意力。支持性证据仍然不完整。本研究旨在评估运动和认知干预相结合对中国轻度认知障碍(COGITO)老年人的有效性。在基于家庭的环境中,由数字治疗授权,并由健康行动过程模型和计划行为理论(HAPA-TPB理论)指导。
方法:本研究是一项随机对照研究,评估者盲法多中心研究。四个平行组将包括总共160名患者,接受联合锻炼和认知干预,孤立的运动干预,孤立的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,超过3个月。所有干预措施将在家中交付,并通过RehabApp和迷你程序进行远程监控,还有一个手臂上的心率遥测装置.具体来说,主管将收到参与者的实时培训日记,心率或其他在线监测数据,然后提供每周电话和每月家访,以鼓励参与者完成他们的任务,并根据他们的培训信息解决任何困难。符合条件的参与者是没有规律运动习惯并被诊断患有MCI的社区居住患者。主要结果是通过阿尔茨海默病评估量表-认知(ADAS-Cog)和痴呆社区筛查工具(CSI-D)评估的认知功能,进行基线和三项随访评估。次要结果包括生活质量,身体健康,睡眠质量,内在能力,脆弱,社会支持,坚持,成本效益和成本效益。
背景:该研究获得了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,并在同行评审的期刊上发表,国家和国际会议。
背景:ChiCTR2300073900。
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
BACKGROUND: ChiCTR2300073900.