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临床试验/NCT05483790
NCT05483790已完成不适用

Enhancing Latent Cognitive Capacity in Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment(MCI): a RCT Study

Huashan Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
cognitive function assessed by the Mini-Mental State Examination (MMSE)

研究概览

简要总结

The study aiming to investigate the efficacy, safety, and potential mechanism of a multimodal intervention on cognitive function in individuals with MCI or the cognitive normal elderly living in a community. The recruited elderly aged 50-75 years with normal cognitive function or MCI will be divided into the intervention group or the control group randomly. The intervention group will be accepted a multidimensional non-pharmacological intervention (cognitive training, physical exercise, healthy lifestyle intervention, and computerized interaction training) while the control group receives health education. Sociodemographics will be collected before the intervention. comprehensive neuropsychological tests and MRI will be collected before and 6 weeks, 12 weeks, 3 months, 6 months, 12 months after the randomization respectively.

详细描述

This study is a 6-week training phase and 6-week maintenance phase randomized controlled trial, conducted at Xinzhuang Town, Minhang District, Shanghai, China.

All participants (control and intervention group) complete the data collection. Demographic data will be collected before intervention including age, sex, education, marriage, etc. A comprehensive cognitive assessment and MRI will be done before and 6 weeks, 12 weeks,3 months, 6 months, 12 months after the randomization respectively.

The intervention group receive four intervention components including cognitive training, physical exercise, healthy lifestyle intervention, and computerized cognitive training. a multimodal intervention program (with schedule) was conducted in the intervention group for 6-week training phase and 6-week maintenance, including cognitive training, physical exercise, healthy lifestyle education, and computerized interaction training. Throughout the 12-week period, the control group only received 30-minute health education through booklets, home visits, or phone calls once every week. The multimodal intervention program included the in-person training course (90-minute, once per week for 6 weeks), computerized interaction training (30-minute, 3 times per week for 6 weeks), and homework (30-minute, every day for 12 weeks).

The in-person training course started with a 10-minute period of reminiscence and discussion. Subsequently, cognitive training activities were conducted for 25 minutes, followed by a 15-minute healthy lifestyle education. After a 10-minute break, physical exercise training was administered for 15 minutes. Finally, participants summarized the all-training activities, either through writing or discussion, and planed their homework during a 15-minute wrap-up session.

The cognitive training encompassed memory-related training (i.e. picture recall, categorization, cueing, repetition, association, sentence formation, story construction, utilization of the Roman room method, face-name association, and verbalization to aid retention) and attention-related training (i.e. character-picture association, idiom-picture association, and spot-the-difference tasks were incorporated). The physical exercise included finger exercises, elastic band exercises, Tai Chi/ Baduanjin with guidance. The healthy lifestyle education included guidance on nutrition, sleep, stress management, and mood adjustment by teaching problem-solving skills, such as managing stressful life events and handling anger and frustration. Additionally, the intervention provided information and support to facilitate lifestyle changes and included discussions and practical exercises, such as tools for assessing dietary behavior.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

single-blinding was pursued as much as possible: group allocation was not actively disclosed to participants, they were advised not to discuss the intervention during testing sessions, opportunities for between-group interactions were restricted, and outcome assessors were blinded to allocation and were not involved in the intervention activities.

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥50 and ≤75 years, Male or Female
  • The resident elderly or those who have lived in the sampled community for more than 6 months
  • Be able to communicate with investigators and understand the questionnaire questions
  • More than 6 years of education
  • Mild cognitive impairment according to the Peterson criteria
  • Volunteer to participate in the study

排除标准

  • Individuals with neurological diseases
  • Cognitive decline due to other disorders (cerebrovascular disease, central nervous system infections, etc.)
  • Mental Disorders included in The Diagnostic and Statistical Manual of Mental Disorders of The American Psychiatric Association
  • Blindness, aphasia, or severe hearing impairment
  • History of myocardial infarction within the previous year, Unstable cardiac, renal, lung, liver or other severe chronic diseases
  • Coincident participation in another intervention trial
  • Using pharmacologic therapeutics for cognitive impairment.

结局指标

主要结局

cognitive function assessed by the Mini-Mental State Examination (MMSE)

时间窗: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention

MMSE using the Chinese version revised by Zhang Mingyuan, the scale includes 30 items, including orientation, instantaneous memory, attention, computation, recall, language and visuospatial. The MMSE score ranges from 0 to 30 (30=best).

次要结局

  • memory function assessed by AVLT(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • memory function assessed by LMT(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • executive function assessed by TMT-A(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • concentration function assessed by DST(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • quality of life assessed by the Barthel index(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • executive function assessed by DSST(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • quality of sleep assessed by PSQI(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • cognitive function assessed by The Montreal Cognitive Assessment (MoCA)(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • quality of life assessed by EQ-5D-5L(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • quality of life assessed by IADL(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • quality of life assessed by PSMS(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • quality of life assessed by SF-36(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • social support assessed by SSRS(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)
  • emotion assessed by GDS-15(6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang Yanyan

Professor (Department of General Medicine, Department of Geriatrics)

Huashan Hospital

研究点 (1)

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