跳至主要内容
临床试验/NCT07588867
NCT07588867已完成不适用

Elderly Disability (Dementia) Prevention and Intervention Project in Jinjiang Community, China

Xiaoying Wang1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2024年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
235
试验地点
1
主要终点
Cognitive Function

研究概览

简要总结

This project aims to test whether a combined multicomponent (CM) program - including health education, cognitive training, and traditional Chinese exercises - is feasible and effective for rural older adults who are at high risk of mild cognitive impairment (MCI). The program is designed to help maintain or improve cognitive function and overall well-being.

详细描述

Health education sessions: One 30-minute lecture every 4 weeks, covering topics such as diet, sleep, chronic disease management, and brain health.

Cognitive training: Weekly 45-minute sessions using fun mini-games to train memory, attention, arithmetic, and logical thinking.

Physical exercise: Weekly 45-minute sessions of traditional Chinese exercises (Baduanjin and Shiqiaoshou) to improve balance, flexibility, and fitness.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 60;
  • Suffering from chronic diseases, such as hypertension, diabetes mellitus, hyperlipidemia, cardiovascular and cerebrovascular diseases, or osteoarthritis;
  • Mild cognitive impairment (defined as Mini-Mental State Examination (MMSE) score of 21-26 combined with either an AD8 self-rated cognitive impairment score ≥ 2 or a digit span (backward) test (DST) score < 4);
  • Mild physical impairment (defined as an Activities of Daily Living (ADL) score < 26 and a Short Physical Performance Battery (SPPB) score of 7-10).

排除标准

  • Age <60;
  • Unable to move physically;
  • Already suffering from Alzheimer's disease.

研究组 & 干预措施

CM intervention group

Experimental

The CM intervention was a 24-week comprehensive program integrating health education, cognitive training, and physical exercise. The health education sessions were delivered once every four weeks, with each session lasting 30 minutes. In contrast, cognitive training and physical exercise sessions were conducted weekly, each with a duration of 45 minutes.

干预措施: the Combined Multicomponent(CM) Intervention (Behavioral)

Control group

No Intervention

the group that does not receive the intervention

结局指标

主要结局

Cognitive Function

时间窗: From enrollment to the end of intervention at 48 weeks

Cognitive function was assessed using the Minimum Mental State Examination (MMSE) scale (Folstein, Folstein, \& McHugh, 1975).The MMSE evaluates five domains: orientation, registration, attention and calculation, recall, and language abilities. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.

次要结局

  • Body Mass Index(From enrollment to the end of intervention at 48 weeks)
  • Waist circumference(From enrollment to the end of intervention at 48 weeks)
  • Blood pressure(From enrollment to the end of intervention at 48 weeks)
  • Activities of daily living(From enrollment to the end of intervention at 48 weeks)
  • Physical performance(From enrollment to the end of intervention at 48 weeks)
  • Participant adherence(From enrollment to the end of intervention at 48 weeks)
  • Participant satisfaction(From intervention at 36 weeks to the end of intervention at 48 weeks)

研究者

发起方
Xiaoying Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiaoying Wang

Investigator

Xiamen University

研究点 (1)

Loading locations...

相似试验