PDF(Pubmed)
Abstract：
UNASSIGNED: Though considered a late-onset disease, the 2020 report of the Lancet Commission emphasizes the necessity of conducting primary prevention trials with an approach of never too early in the life course for dementia prevention. Driven by the same notion, we hereby aim to compare the dementia risk reduction potential of two potential interventions, 48 weeks (12 months) of yoga and brisk walking, in middle-aged high-risk subjects.
UNASSIGNED: A randomized controlled trial.
UNASSIGNED: Community in India.
UNASSIGNED: In total, 323 at-risk dementia subjects will be recruited from community settings through health awareness camps and door-to-door surveys across Delhi, India. Participants will be randomized into yoga or brisk-walking groups (1:1). The yoga intervention group will receive 60 contact yoga sessions per 60-min/day at the community parks, followed by continued tele-supervised home practice, further followed by at-home self-practice, and will be tested at 3-time points (baseline, 24-week and 48-week, post-randomization) to test the efficacy of the intervention. The control group will be asked to do brisk walking daily for 45 minutes at their convenience, followed by weekly telephone follow-ups. Applying the intention-to-treat principle, the primary endpoint will be the change from baseline at the 12th month in the Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) Scores. Secondary outcomes will include the composite scores derived from a comprehensive neuropsychology battery, comprising the Trail Making Test, Digit Span Test, N Back, Color Trail, Animal Fluency Test, COWA (Controlled Oral Word Association Test), and Digit Symbol Substitution. The primary outcome will be analyzed using mixed-effect models for repeated measures, adjusted for covariates as fixed effects. The study has been prospectively registered (CTRI/2023/02/049746) on February 15, 2023. The protocol was conceptualized in 2021 and approved by the Institutional Ethics Committee of SVYASA. Recruitment began in February 2023 and is underway with patient enrollment.
UNASSIGNED: To our knowledge, this is the first controlled trial to investigate the longitudinal effects of a yoga-based intervention on dementia risk reduction using the CAIDE risk score. The findings of this trial will also provide insight into a better understanding of genotype-dependent responses to yoga intervention and open up avenues for understanding the implications of gene-intervention interactions for precision prevention using yoga.
UNASSIGNED: A randomized controlled trial.
UNASSIGNED: Community in India.
UNASSIGNED: In total, 323 at-risk dementia subjects will be recruited from community settings through health awareness camps and door-to-door surveys across Delhi, India. Participants will be randomized into yoga or brisk-walking groups (1:1). The yoga intervention group will receive 60 contact yoga sessions per 60-min/day at the community parks, followed by continued tele-supervised home practice, further followed by at-home self-practice, and will be tested at 3-time points (baseline, 24-week and 48-week, post-randomization) to test the efficacy of the intervention. The control group will be asked to do brisk walking daily for 45 minutes at their convenience, followed by weekly telephone follow-ups. Applying the intention-to-treat principle, the primary endpoint will be the change from baseline at the 12th month in the Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) Scores. Secondary outcomes will include the composite scores derived from a comprehensive neuropsychology battery, comprising the Trail Making Test, Digit Span Test, N Back, Color Trail, Animal Fluency Test, COWA (Controlled Oral Word Association Test), and Digit Symbol Substitution. The primary outcome will be analyzed using mixed-effect models for repeated measures, adjusted for covariates as fixed effects. The study has been prospectively registered (CTRI/2023/02/049746) on February 15, 2023. The protocol was conceptualized in 2021 and approved by the Institutional Ethics Committee of SVYASA. Recruitment began in February 2023 and is underway with patient enrollment.
UNASSIGNED: To our knowledge, this is the first controlled trial to investigate the longitudinal effects of a yoga-based intervention on dementia risk reduction using the CAIDE risk score. The findings of this trial will also provide insight into a better understanding of genotype-dependent responses to yoga intervention and open up avenues for understanding the implications of gene-intervention interactions for precision prevention using yoga.
摘要：
■虽然被认为是一种迟发性疾病，柳叶刀委员会2020年的报告强调了进行一级预防试验的必要性,在预防痴呆症的生命过程中,采取永远不要过早的方法.在同样的概念驱动下，我们在此旨在比较两种潜在干预措施的降低痴呆症风险的潜力，48周（12个月）的瑜伽和快走，在中年高危人群中。
■一项随机对照试验。
■印度社区。
■总共，将通过德里各地的健康意识营地和挨家挨户的调查，从社区环境中招募323名有风险的痴呆症受试者，印度。参与者将被随机分为瑜伽或快走组（1：1）。瑜伽干预小组将在社区公园每60分钟/天接受60次接触瑜伽课程，随后继续进行远程监督的家庭实践，其次是在家自我练习，并将在3个时间点进行测试(基线，24周和48周,随机化后)测试干预的疗效。对照组将被要求在方便的时候每天快走45分钟，其次是每周电话随访。运用意向治疗原则，主要终点是第12个月心血管危险因素的基线变化，衰老,和痴呆症（CAIDE）得分。次要结果将包括来自全面神经心理学电池的综合评分，包括跟踪测试，数字跨度测试,N后退,颜色踪迹,动物流畅度测试,COWA（受控口头单词联想测试），和数字符号替换。主要结果将使用重复测量的混合效应模型进行分析，将协变量调整为固定效应。该研究已于2023年2月15日进行了前瞻性注册（CTRI/2023/02/049746）。该方案于2021年概念化，并由SVYASA机构伦理委员会批准。招募始于2023年2月，目前正在进行患者招募。
■据我们所知，这是首个使用CAIDE风险评分研究基于瑜伽的干预对降低痴呆风险的纵向影响的对照试验.该试验的结果还将提供对基因型依赖性瑜伽干预反应的深入了解，并为理解基因干预相互作用对使用瑜伽进行精确预防的意义开辟途径。
■一项随机对照试验。
■印度社区。
■总共，将通过德里各地的健康意识营地和挨家挨户的调查，从社区环境中招募323名有风险的痴呆症受试者，印度。参与者将被随机分为瑜伽或快走组（1：1）。瑜伽干预小组将在社区公园每60分钟/天接受60次接触瑜伽课程，随后继续进行远程监督的家庭实践，其次是在家自我练习，并将在3个时间点进行测试(基线，24周和48周,随机化后)测试干预的疗效。对照组将被要求在方便的时候每天快走45分钟，其次是每周电话随访。运用意向治疗原则，主要终点是第12个月心血管危险因素的基线变化，衰老,和痴呆症（CAIDE）得分。次要结果将包括来自全面神经心理学电池的综合评分，包括跟踪测试，数字跨度测试,N后退,颜色踪迹,动物流畅度测试,COWA（受控口头单词联想测试），和数字符号替换。主要结果将使用重复测量的混合效应模型进行分析，将协变量调整为固定效应。该研究已于2023年2月15日进行了前瞻性注册（CTRI/2023/02/049746）。该方案于2021年概念化，并由SVYASA机构伦理委员会批准。招募始于2023年2月，目前正在进行患者招募。
■据我们所知，这是首个使用CAIDE风险评分研究基于瑜伽的干预对降低痴呆风险的纵向影响的对照试验.该试验的结果还将提供对基因型依赖性瑜伽干预反应的深入了解，并为理解基因干预相互作用对使用瑜伽进行精确预防的意义开辟途径。
