采用个性化方法逆转认知功能衰弱的多领域干预(AGELESS 试验):参与者的招募和基线特征

A. M. Ibrahim, D. K. A. Singh, A. F. M. Ludin, P. Subramaniam, C. Ai-Vyrn, N. Ibrahim, H. Haron, A. M. Safien, N. M. Khalid, P. Ponvel, N. H. M. Fadzil, J. M. Hanipah, F. Mangialasche, M. Kivipelto, Suzana Shahar
{"title":"采用个性化方法逆转认知功能衰弱的多领域干预(AGELESS 试验):参与者的招募和基线特征","authors":"A. M. Ibrahim, D. K. A. Singh, A. F. M. Ludin, P. Subramaniam, C. Ai-Vyrn, N. Ibrahim, H. Haron, A. M. Safien, N. M. Khalid, P. Ponvel, N. H. M. Fadzil, J. M. Hanipah, F. Mangialasche, M. Kivipelto, Suzana Shahar","doi":"10.14283/jpad.2024.111","DOIUrl":null,"url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Reversal of cognitive frailty through a multidomain intervention is desirable to prevent dementia. AGELESS Trial was conducted to determine the effectiveness of a comprehensive, multidomain intervention on older adults with cognitive frailty in Malaysia. However, conducting a clinical trial, particularly during and after Covid-19, posed unique challenges.</p><h3 data-test=\"abstract-sub-heading\">Objective</h3><p>We aimed to investigate the recruitment process and baseline characteristics of the AGELESS Trial participants to better understand an at-risk population and those who agree to participate in an intervention.</p><h3 data-test=\"abstract-sub-heading\">Design/Setting</h3><p>24-month, randomized controlled trial.</p><h3 data-test=\"abstract-sub-heading\">Participants</h3><p>Community-dwelling older adults with independent mobility, aged ≥ 60 years, with a mini mental state examination score of 19–25, a clinical dementia rating of 0.5 ≥ 1 Fried’s physical frailty criteria, and &lt; 22 Beck depression inventory.</p><h3 data-test=\"abstract-sub-heading\">Intervention</h3><p>Participants were randomized 1:1 to a structured multidomain intervention consisting of vascular management, diet, exercise, cognitive and psychosocial stimulation, or to the arm, including routine care and general health consultation.</p><h3 data-test=\"abstract-sub-heading\">Measurement</h3><p>We analyzed the group differences between (1) cognitive frailty and non-cognitive frailty screened subjects, (2) recruited and non-recruited participants, (3) baseline characteristics of participants by arm, (4) adherence to AGELESS intervention at 12 months, and (5) preliminary findings on the effectiveness of the intervention at 12 months.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>A total of 957 older adults from two locations, i.e., urban (n = 764) and rural (n = 193) areas, were screened, of whom 38.9% had cognitive frailty and were eligible to participate. Those with cognitive frailty had fewer years of education (B = −0.08; 95%CI = 0.88–0.97; p = 0.002), and lower functioning cognition (B = −0.24; 95%CI = 0.74–0.84; p &lt; 0.001). Among those from urban areas, only 33.1% (n = 106) agreed to participate, particularly those with multimorbidity (B = 0.86; 95%CI = 1.31–4.30; p = 0.01), higher physical activity (B = −1.02; 95%CI = 0.19–0.69; p = 0.002), slower walking speed (B = 1.26; 95%CI = 1.62–7.61; p = 0.001), and higher systolic blood pressure (B = 0.02; 95%CI = 1.00–1.03; p = 0.03). At baseline, participants’ mean age was 68.1±5.6, years of education was 8.3±3.9, body mass index was 27.5±5.3 kg/m<sup>2</sup>, and mini mental state examination score was 22.7±4.0. Generally, there were no significant differences between the intervention and control groups for the main outcomes, except those in the intervention group had higher body mass index, mid-upper-arm circumference, and waist circumference (p &lt; 0.05 for all parameters). Overall intervention adherence at 12 months was 52.8%, ranging from 52.8%–90.6% for each of the modules. Preliminary analysis of the effectiveness of the intervention at 12 months was positive on most of the cognitive domains, some of the nutrient intake and food groups, physical function, and vascular outcomes (p &lt; 0.05 for all parameters).</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Despite the challenges posed by the pandemic, screening, recruitment, and 12-month intervention delivery were achieved in a Malaysian multidomain preventive randomized controlled trial in older adults at risk of dementia, with a satisfactory adherence rate and cognitive benefits at 12 months.</p>","PeriodicalId":22711,"journal":{"name":"The Journal of Prevention of Alzheimer's Disease","volume":null,"pages":null},"PeriodicalIF":4.3000,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Multidomain Intervention for the Reversal of Cognitive Frailty Using a Personalized Approach (AGELESS Trial): Recruitment and Baseline Characteristics of Participants\",\"authors\":\"A. M. Ibrahim, D. K. A. Singh, A. F. M. Ludin, P. Subramaniam, C. Ai-Vyrn, N. Ibrahim, H. Haron, A. M. Safien, N. M. Khalid, P. Ponvel, N. H. M. Fadzil, J. M. Hanipah, F. Mangialasche, M. Kivipelto, Suzana Shahar\",\"doi\":\"10.14283/jpad.2024.111\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Background</h3><p>Reversal of cognitive frailty through a multidomain intervention is desirable to prevent dementia. AGELESS Trial was conducted to determine the effectiveness of a comprehensive, multidomain intervention on older adults with cognitive frailty in Malaysia. However, conducting a clinical trial, particularly during and after Covid-19, posed unique challenges.</p><h3 data-test=\\\"abstract-sub-heading\\\">Objective</h3><p>We aimed to investigate the recruitment process and baseline characteristics of the AGELESS Trial participants to better understand an at-risk population and those who agree to participate in an intervention.</p><h3 data-test=\\\"abstract-sub-heading\\\">Design/Setting</h3><p>24-month, randomized controlled trial.</p><h3 data-test=\\\"abstract-sub-heading\\\">Participants</h3><p>Community-dwelling older adults with independent mobility, aged ≥ 60 years, with a mini mental state examination score of 19–25, a clinical dementia rating of 0.5 ≥ 1 Fried’s physical frailty criteria, and &lt; 22 Beck depression inventory.</p><h3 data-test=\\\"abstract-sub-heading\\\">Intervention</h3><p>Participants were randomized 1:1 to a structured multidomain intervention consisting of vascular management, diet, exercise, cognitive and psychosocial stimulation, or to the arm, including routine care and general health consultation.</p><h3 data-test=\\\"abstract-sub-heading\\\">Measurement</h3><p>We analyzed the group differences between (1) cognitive frailty and non-cognitive frailty screened subjects, (2) recruited and non-recruited participants, (3) baseline characteristics of participants by arm, (4) adherence to AGELESS intervention at 12 months, and (5) preliminary findings on the effectiveness of the intervention at 12 months.</p><h3 data-test=\\\"abstract-sub-heading\\\">Results</h3><p>A total of 957 older adults from two locations, i.e., urban (n = 764) and rural (n = 193) areas, were screened, of whom 38.9% had cognitive frailty and were eligible to participate. Those with cognitive frailty had fewer years of education (B = −0.08; 95%CI = 0.88–0.97; p = 0.002), and lower functioning cognition (B = −0.24; 95%CI = 0.74–0.84; p &lt; 0.001). Among those from urban areas, only 33.1% (n = 106) agreed to participate, particularly those with multimorbidity (B = 0.86; 95%CI = 1.31–4.30; p = 0.01), higher physical activity (B = −1.02; 95%CI = 0.19–0.69; p = 0.002), slower walking speed (B = 1.26; 95%CI = 1.62–7.61; p = 0.001), and higher systolic blood pressure (B = 0.02; 95%CI = 1.00–1.03; p = 0.03). At baseline, participants’ mean age was 68.1±5.6, years of education was 8.3±3.9, body mass index was 27.5±5.3 kg/m<sup>2</sup>, and mini mental state examination score was 22.7±4.0. Generally, there were no significant differences between the intervention and control groups for the main outcomes, except those in the intervention group had higher body mass index, mid-upper-arm circumference, and waist circumference (p &lt; 0.05 for all parameters). Overall intervention adherence at 12 months was 52.8%, ranging from 52.8%–90.6% for each of the modules. Preliminary analysis of the effectiveness of the intervention at 12 months was positive on most of the cognitive domains, some of the nutrient intake and food groups, physical function, and vascular outcomes (p &lt; 0.05 for all parameters).</p><h3 data-test=\\\"abstract-sub-heading\\\">Conclusion</h3><p>Despite the challenges posed by the pandemic, screening, recruitment, and 12-month intervention delivery were achieved in a Malaysian multidomain preventive randomized controlled trial in older adults at risk of dementia, with a satisfactory adherence rate and cognitive benefits at 12 months.</p>\",\"PeriodicalId\":22711,\"journal\":{\"name\":\"The Journal of Prevention of Alzheimer's Disease\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2024-06-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Journal of Prevention of Alzheimer's Disease\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14283/jpad.2024.111\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"BUSINESS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Journal of Prevention of Alzheimer's Disease","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14283/jpad.2024.111","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"BUSINESS","Score":null,"Total":0}
引用次数: 0

摘要

背景通过多领域干预扭转认知虚弱状况是预防痴呆症的理想方法。AGELESS试验旨在确定对马来西亚认知虚弱老年人进行多领域综合干预的有效性。目标我们旨在调查 AGELESS 试验参与者的招募过程和基线特征,以更好地了解高危人群和同意参与干预的人群。设计/设置为期 24 个月的随机对照试验。参与者社区居住的独立行动老年人,年龄≥ 60 岁,迷你精神状态检查评分为 19-25 分,临床痴呆评分为 0.5 ≥ 1 分,符合弗里德身体虚弱标准,以及 < 22 贝克抑郁量表。干预参与者按 1:1 随机分配到由血管管理、饮食、运动、认知和社会心理刺激组成的结构化多领域干预中,或分配到包括常规护理和一般健康咨询在内的干预组中。测量我们分析了以下方面的群体差异:(1) 认知虚弱和非认知虚弱筛查对象;(2) 已招募和未招募的参与者;(3) 各组参与者的基线特征;(4) 12 个月内坚持 AGELESS 干预的情况;(5) 12 个月内干预效果的初步结果、结果 两地共筛选出 957 名老年人,即城市地区(764 人)和农村地区(193 人),其中 38.9% 的老年人认知能力较弱,符合参与条件。认知功能虚弱者受教育年限较少(B = -0.08; 95%CI = 0.88-0.97; p = 0.002),认知功能较弱(B = -0.24; 95%CI = 0.74-0.84; p <0.001)。在来自城市地区的人群中,仅有 33.1%(n = 106)的人同意参与,尤其是那些患有多种疾病(B = 0.86; 95%CI = 1.31-4.30; p = 0.01)、体力活动较多(B = -1.02; 95%CI = 0.19-0.69; p = 0.002),步行速度较慢(B = 1.26; 95%CI = 1.62-7.61; p = 0.001),收缩压较高(B = 0.02; 95%CI = 1.00-1.03; p = 0.03)。基线时,参与者的平均年龄为(68.1±5.6)岁,受教育年限为(8.3±3.9)年,体重指数为(27.5±5.3)kg/m2,迷你精神状态检查评分为(22.7±4.0)分。总体而言,干预组和对照组在主要结果上没有明显差异,只是干预组的体重指数、中上臂围和腰围更高(所有参数的 p 均为 0.05)。12 个月时,干预组的总体坚持率为 52.8%,每个模块的坚持率从 52.8% 到 90.6% 不等。对 12 个月干预效果的初步分析表明,干预对大多数认知领域、部分营养素摄入和食物组、身体功能和血管结果都有积极作用(所有参数的 p 均为 0.05)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Multidomain Intervention for the Reversal of Cognitive Frailty Using a Personalized Approach (AGELESS Trial): Recruitment and Baseline Characteristics of Participants

Background

Reversal of cognitive frailty through a multidomain intervention is desirable to prevent dementia. AGELESS Trial was conducted to determine the effectiveness of a comprehensive, multidomain intervention on older adults with cognitive frailty in Malaysia. However, conducting a clinical trial, particularly during and after Covid-19, posed unique challenges.

Objective

We aimed to investigate the recruitment process and baseline characteristics of the AGELESS Trial participants to better understand an at-risk population and those who agree to participate in an intervention.

Design/Setting

24-month, randomized controlled trial.

Participants

Community-dwelling older adults with independent mobility, aged ≥ 60 years, with a mini mental state examination score of 19–25, a clinical dementia rating of 0.5 ≥ 1 Fried’s physical frailty criteria, and < 22 Beck depression inventory.

Intervention

Participants were randomized 1:1 to a structured multidomain intervention consisting of vascular management, diet, exercise, cognitive and psychosocial stimulation, or to the arm, including routine care and general health consultation.

Measurement

We analyzed the group differences between (1) cognitive frailty and non-cognitive frailty screened subjects, (2) recruited and non-recruited participants, (3) baseline characteristics of participants by arm, (4) adherence to AGELESS intervention at 12 months, and (5) preliminary findings on the effectiveness of the intervention at 12 months.

Results

A total of 957 older adults from two locations, i.e., urban (n = 764) and rural (n = 193) areas, were screened, of whom 38.9% had cognitive frailty and were eligible to participate. Those with cognitive frailty had fewer years of education (B = −0.08; 95%CI = 0.88–0.97; p = 0.002), and lower functioning cognition (B = −0.24; 95%CI = 0.74–0.84; p < 0.001). Among those from urban areas, only 33.1% (n = 106) agreed to participate, particularly those with multimorbidity (B = 0.86; 95%CI = 1.31–4.30; p = 0.01), higher physical activity (B = −1.02; 95%CI = 0.19–0.69; p = 0.002), slower walking speed (B = 1.26; 95%CI = 1.62–7.61; p = 0.001), and higher systolic blood pressure (B = 0.02; 95%CI = 1.00–1.03; p = 0.03). At baseline, participants’ mean age was 68.1±5.6, years of education was 8.3±3.9, body mass index was 27.5±5.3 kg/m2, and mini mental state examination score was 22.7±4.0. Generally, there were no significant differences between the intervention and control groups for the main outcomes, except those in the intervention group had higher body mass index, mid-upper-arm circumference, and waist circumference (p < 0.05 for all parameters). Overall intervention adherence at 12 months was 52.8%, ranging from 52.8%–90.6% for each of the modules. Preliminary analysis of the effectiveness of the intervention at 12 months was positive on most of the cognitive domains, some of the nutrient intake and food groups, physical function, and vascular outcomes (p < 0.05 for all parameters).

Conclusion

Despite the challenges posed by the pandemic, screening, recruitment, and 12-month intervention delivery were achieved in a Malaysian multidomain preventive randomized controlled trial in older adults at risk of dementia, with a satisfactory adherence rate and cognitive benefits at 12 months.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
The Journal of Prevention of Alzheimer's Disease
The Journal of Prevention of Alzheimer's Disease Medicine-Psychiatry and Mental Health
CiteScore
9.20
自引率
0.00%
发文量
0
期刊介绍: The JPAD Journal of Prevention of Alzheimer’Disease will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including: neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes.JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.We hope that JPAD with your contribution will play a role in the development of Alzheimer prevention.
期刊最新文献
Association between Cognitive Reserve Indicator and Chronic Disease-Free Survival: A Large Community-Based Longitudinal Study Phase 1 Studies of the Anti-Tau Monoclonal Antibody JNJ-63733657 in Healthy Participants and Participants with Alzheimer’s Disease Roles of TREM2 in the Pathological Mechanism and the Therapeutic Strategies of Alzheimer’s Disease Development and Validation the Mobile Toolbox (MTB) Spelling Test Correlates of Subjective Cognitive Decline in Black American Men
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1