通过改善认知和步态能力以及使用辅助产品促进体弱老年人的独立生活 (MIND&GAIT)
MIND&GAIT - 通过提高认知和步态能力以及使用辅助产品促进体弱老年人的独立生活
研究概览
详细说明
在老龄化社会日益加剧的背景下,机构中老年人的数量趋于增加。 有几个原因导致老年人被制度化,包括身体和认知能力下降。 在葡萄牙,60 岁以上的人口中,约有 160,287 人患有痴呆症,占该年龄段人口的 5.91%。 轻度认知障碍 (MCI) 被认为是正常认知老化和轻度痴呆之间的中间状态,尤其是在老年人中。 它越来越被认为是与痴呆症风险增加相关的主要健康问题。 认知健康维护对于预防认知障碍和延缓痴呆症、依赖性和(无)自我保健能力的发作至关重要。 对于认知能力下降的老年人,认知刺激可能是一种很有前途的干预措施,可以减轻抑郁症状和抑郁脆弱性,改善他们的生活质量。 另一方面,健康老龄化传统上侧重于疾病预防,但需要付出更大的努力来减少老年人的虚弱和依赖,并保持老年人的独立身体和认知功能。 与久坐不动的生活方式相关的衰老过程会导致某些身体机能下降。 保持功能状态和减少与年龄相关的发病率是积极老龄化政策的重要组成部分;它促进独立生活,提高生活质量,并降低医疗保健费用。 通过这种方式,锻炼计划可以减少与年龄相关的功能能力下降,并保持 65-85 岁成年人的肌肉力量和质量。
研究小组打算干预促进积极老龄化,包括体育锻炼和促进延缓和/或维持体弱老年人认知和身体健康的活动。
以这种方式,研究团队将进行一项随机对照试验,该研究团队由两组组成:实验组(CI组)和对照组。 本研究的目的是评估 CI 计划对体弱老年人的影响。 联合干预有效性的评估将采用以下方法:
- 样品测试:为了计算样品量,使用了软件 G*Power 3.1.9.2。 功效分析基于 0.05 的 I 类错误; 0.80 的功效;效应量 f=0.30;和ANOVA:因素之间的重复测量确定总样本量为62。将从两个养老院中招募65岁或以上的参与者。 参与者将随机分配到对照组和实验组中,每组 8 人。 参与者将被归类为具有轻度至中度认知能力下降和轻度至中度跌倒风险。 对照组将接受常规护理。
-干预:联合干预将实施 21 周,每周 4 次。 认知刺激计划 (CSP) 将每周应用一次,体育活动计划 (PAP) 每周应用 3 次,持续 30-60 分钟。 在执行 PAP 期间,使用滚动助行器的参与者将受益于滚动助行器机制 (ABMRW) 的自动阻塞套件机制。
-数据分析:通过重复测量和方差分析进行统计分析。 年龄、性别以及抑郁症和日常生活活动 (ADL) 的初始评分将作为协变量引入。 将进行意向治疗分析以分析离开研究的人的数据。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Coimbra、葡萄牙、3000-232
- Health Sciences Research Unit: Nursing
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 65岁或以上的长者;
- 能够以知情方式同意其参与研究的老年人;
- 具有允许他们参与联合干预的临床条件的老年人;
- 根据 6-CIT 量表,具有轻度至中度认知脆弱标准的老年人;
- 根据老年抑郁量表(15 项版本),患有轻度至中度抑郁状态的老年人。
- Tinetti 指数追踪存在轻度至中度跌倒风险的老年人;
- 通过生物力学步态参数跟踪身体虚弱的老年人。
排除标准:
- 临床情况不稳定的老年人;
- 患有心脏病的老年人可以进行体育锻炼;
- 没有参与研究意愿的老年人。
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:控制组
将分配到对照组的参与者将接受机构常规护理。
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实验性的:联合干预组
将被分配到实验组的参与者将接受联合干预计划
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实验:联合干预计划由认知刺激计划(CSP)、身体活动计划(PAP)和动物辅助治疗(AAT)组成。
在使用助行器的 PAP 参与者期间,将使用适用于助行器的自动阻塞套件机制 (ABMRW) 进行 PAP。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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参与者认知中的基线变化
大体时间:中期评估(第 12 周)
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结果测量:“蒙特利尔认知评估 (MoCA)”- Freitas, S., Simões, M. R., Santana, I., Martins, C. & Nasreddine, Z. (2013) 的葡萄牙语版本。
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中期评估(第 12 周)
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参与者认知中的基线变化
大体时间:干预后评估(第 21 周)
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结果测量:“蒙特利尔认知评估 (MoCA)”- Freitas, S., Simões, M. R., Santana, I., Martins, C. & Nasreddine, Z. (2013) 的葡萄牙语版本。
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干预后评估(第 21 周)
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参与者身体虚弱的基线变化
大体时间:中期评估(第 12 周)
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结果测量:“步态 B”与将适应特定环境的秒表。
它还将使用新型 EMED-X 压力平台测量步态的生物力学参数。
跌倒风险将使用“Tinetti 指数”来衡量,这是 Tinetti、Wiliams 和 Mayewski (1986) 的原始版本,由 Elisa Petiz (2001) 翻译并改编成葡萄牙语。
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中期评估(第 12 周)
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参与者身体虚弱的基线变化
大体时间:干预后评估(第 21 周)
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结果测量:“步态 B”与将适应特定环境的秒表。
它还将使用新型 EMED-X 压力平台测量步态的生物力学参数。
跌倒风险将使用“Tinetti 指数”来衡量,这是 Tinetti、Wiliams 和 Mayewski (1986) 的原始版本,由 Elisa Petiz (2001) 翻译并改编成葡萄牙语。
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干预后评估(第 21 周)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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参与者日常生活活动的基线变化
大体时间:中期评估(第 12 周)
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结果测量:“Barthel ADL 指数 - 葡萄牙语版”
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中期评估(第 12 周)
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参与者日常生活活动的基线变化
大体时间:干预后评估(第 21 周)
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结果测量:“Barthel ADL 指数 - 葡萄牙语版”
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干预后评估(第 21 周)
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合作者和调查者
合作者
调查人员
- 首席研究员:João Apóstolo, Aggregation、Nursing School of Coimbra (ESEnfC)
出版物和有用的链接
一般刊物
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- Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. doi: 10.1016/0002-9343(86)90717-5.
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- Apostolo J, Cooke R, Bobrowicz-Campos E, Santana S, Marcucci M, Cano A, Vollenbroek-Hutten M, Germini F, Holland C. Predicting risk and outcomes for frail older adults: an umbrella review of frailty screening tools. JBI Database System Rev Implement Rep. 2017 Apr;15(4):1154-1208. doi: 10.11124/JBISRIR-2016-003018.
- Kojima G. Prevalence of Frailty in Nursing Homes: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2015 Nov 1;16(11):940-5. doi: 10.1016/j.jamda.2015.06.025. Epub 2015 Aug 6.
- Sternberg SA, Wershof Schwartz A, Karunananthan S, Bergman H, Mark Clarfield A. The identification of frailty: a systematic literature review. J Am Geriatr Soc. 2011 Nov;59(11):2129-38. doi: 10.1111/j.1532-5415.2011.03597.x. Epub 2011 Sep 21.
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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联合干预组的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
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Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完全的
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Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart Association完全的