基于棋类和纸牌的休闲活动对改善老年人认知能力的影响：一项整群随机对照试验的研究方案。
The effect of the leisure activities based on chess and cards for improving cognition of older adults: study protocol for a cluster randomized controlled trial.
机构信息
Department of Epidemiology and Health Statistics, School of Public Health, Ningxia Medical University, Yinchuan, 750004, China.
Key Laboratory of Environmental Factors and Chronic Disease Control, Ningxia Medical University, Hui Autonomous Region, Yinchuan, 750004, Ningxia, China.
出版信息
Trials. 2023 Jul 29;24(1):484. doi: 10.1186/s13063-023-07528-1.
BACKGROUND
With the increase in age, the probability of cognitive impairment in the older people is increasing. More and more evidence shows that participating in leisure activities, especially chess and cards, is beneficial to the cognition and mental state of the older people. But the evidence for causal inference is limited. There is a need to conduct a fully powered randomized controlled trial (RCT) and long-term follow-up to test the effectiveness of intervention measures in improving cognitive function and mental state. This paper describes the methodology of a cluster RCT designed to determine the effect of chess and cards leisure activities on the cognitive function of the older people over 60 years old.
METHODS/DESIGN: A cluster RCT consisting of 8 clusters will be conducted in four regions of Ningxia, China (Helan, Litong, Qingtongxia, and Shapotou). Clusters will be randomly assigned to the advocacy intervention group, which is also delivered with free leisure activities tools (chess and cards), or the control group. A baseline survey will be conducted before the intervention. A mid-term and final survey will be carried out twelve and twenty-four months after the intervention, respectively. The primary outcome is a change in cognitive function, and the secondary outcomes are changes in anxiety, depression, and loneliness.
DISCUSSION
The results of this RCT will be helpful to (1) confirm the effectiveness of chess and cards leisure activities in improving the cognitive function of the older people over 60 years old; (2) determine the relationship between the frequency and duration of chess and cards leisure activities and cognitive function; (3) provide evidence of promoting participation in leisure activities through education campaigns and free provision of chess and cards tools; and (4) provide valuable information for successful aging.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR2200066817. Registered on 19 December 2022.
背景
随着年龄的增长，老年人认知障碍的概率逐渐增加。越来越多的证据表明，参与休闲活动，尤其是下棋和打牌，有益于老年人的认知和精神状态。但因果推断的证据有限。因此，需要进行一项充分 powered 的随机对照试验（RCT）和长期随访，以测试干预措施改善认知功能和精神状态的有效性。本文描述了一项集群 RCT 的方法学，旨在确定棋牌休闲活动对 60 岁以上老年人认知功能的影响。
方法/设计：这项 RCT 将在中国宁夏的四个地区（贺兰山、利通区、青铜峡和沙坡头）进行，由 8 个集群组成一个集群 RCT。集群将被随机分配到倡导干预组，该组还提供免费的休闲活动工具（棋牌），或对照组。在干预前进行基线调查，在干预后 12 个月和 24 个月分别进行中期和最终调查。主要结局是认知功能的变化，次要结局是焦虑、抑郁和孤独的变化。
讨论
这项 RCT 的结果将有助于：（1）确认棋牌休闲活动对改善 60 岁以上老年人认知功能的有效性；（2）确定棋牌休闲活动的频率和持续时间与认知功能之间的关系；（3）通过教育宣传活动和免费提供棋牌工具，为促进休闲活动的参与提供证据；（4）为成功老龄化提供有价值的信息。
试验注册
中国临床试验注册中心：ChiCTR2200066817。注册于 2022 年 12 月 19 日。
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