Xia Sijia, Chen Feng, Wang Wenju, Jiang Tao, Zhu Jingfang, Yang Lei, Yang Minguang, Xiang Qing, Liu Weilin
College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.
The Institute of Rehabilitation Industry, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.
BMJ Open. 2025 Jun 27;15(6):e094645. doi: 10.1136/bmjopen-2024-094645.
Cognitive frailty (CF) is a clinical syndrome characterised by the concurrent occurrence of physical frailty and cognitive impairment, excluding Alzheimer's disease and other forms of dementia. Recent studies have shown that combining aerobic exercise (AE) and meditation (ME) effectively enhances both physical and cognitive functions in individuals with CF. The study aims to determine whether the combined application of AE and ME can elicit significantly greater improvements in physical and cognitive functions among individuals with CF compared with the independent practice of either AE or ME alone.
The research design employs a four-arm, assessor-blind randomised controlled trial. A total of 140 qualified subjects will be randomly allocated among four groups: AE, ME, AE combined with ME and a health education control group, ensuring equivalent distribution across groups. The intervention phase of the study will last for 12 weeks. The primary outcomes will include the Edmonton Frailty Scale, while secondary outcomes will encompass evaluations of cognitive functions (including global cognitive function, memory, attention, executive function and visuospatial abilities), physical performance (measured by gait speed and lower extremity strength), subjective experiences (such as fatigue, quality of life, mindfulness, mood and sleep quality), as well as structural and functional MRI assessments and serum biomarkers. Outcomes will be evaluated at baseline and following the 12-week intervention.
The Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine granted ethical approval for the study (2023KY-012-02). The findings will be disseminated through publications in peer-reviewed journals and presentations at academic conferences.
ChiCTR2300073563.
认知衰弱(CF)是一种临床综合征,其特征为身体衰弱和认知障碍同时出现,不包括阿尔茨海默病和其他形式的痴呆症。最近的研究表明,有氧运动(AE)和冥想(ME)相结合可有效增强CF患者的身体和认知功能。本研究旨在确定与单独进行AE或ME相比,AE和ME联合应用是否能使CF患者的身体和认知功能得到更显著的改善。
本研究设计采用四臂、评估者盲法随机对照试验。总共140名合格受试者将被随机分配到四组:AE组、ME组、AE与ME联合组和健康教育对照组,确保各组分布均衡。研究的干预阶段将持续12周。主要结局将包括埃德蒙顿衰弱量表,次要结局将包括认知功能评估(包括整体认知功能、记忆、注意力、执行功能和视觉空间能力)、身体表现(通过步速和下肢力量测量)、主观体验(如疲劳、生活质量、正念、情绪和睡眠质量),以及结构和功能磁共振成像评估和血清生物标志物。结局将在基线和12周干预后进行评估。
福建中医药大学附属康复医院伦理委员会批准了本研究(2023KY - 012 - 02)。研究结果将通过在同行评审期刊上发表以及在学术会议上报告进行传播。
ChiCTR2300073563。