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临床试验/NCT02864069
NCT02864069已完成不适用

Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Rivermead Behavioral Memory Test

研究概览

简要总结

Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk for cognitive decline and dementia, with combinations of non-pharmacological interventions providing greatest promise for impacting cognitive aging. This, paired with limited cognitive benefits from pharmacological interventions in dementia, has shifted focus to non-pharmacological interventions administered earlier in the disease course. This application, therefore, proposes a randomized controlled trial (RCT; 12-week active intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided progressive increases in weekly step counts), computer-based cognitive training program (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults with mild cognitive impairment (MCI).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • MCI diagnosis (can be self referral, will determine eligibility at baseline)

排除标准

  • Dementia diagnosis
  • Head trauma
  • Neuro/psychiatric disorders
  • Current substance dependence
  • Sensory/mobility deficits
  • No more than 1 hour of purposeful, aerobic activity/week
  • Currently engaging in any other brain-stimulating computer program (No more than 1 hour a week)

结局指标

主要结局

Rivermead Behavioral Memory Test

时间窗: 12 weeks

The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. Belongings subtest scaled scores: Minimum score = 1, Maximum score = 19; higher values represent better performance.

Everyday Cognition Scale

时间窗: 12 weeks

The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. Average total score was used: Minimum = 1, Maximum = 4, higher scores indicate greater impairment

Older Peoples Quality of Life Questionnaire

时间窗: 12 weeks

Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life.

次要结局

未报告次要终点

研究者

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

Amy Jak

Associate Professor of Psychiatry

University of California, San Diego

研究点 (2)

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