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临床试验/NCT04404621
NCT04404621已完成不适用

Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults

Yale University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年11月13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
34
试验地点
2
主要终点
Composite cognition score

研究概览

简要总结

The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence.

详细描述

The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old will be invited to participate. After providing informed consent, in the case of subjects who are living on units for individuals with memory or other cognitive compromise, after assent from the individual and approval from facility staff, subjects will be randomly assigned to either receive the intervention for 18 weeks and then be followed for an additional 18 weeks, or to be followed for 18 weeks without intervention and then do the intervention for 18 weeks. The intervention will consist of 18 weeks of 60-minute PE sessions 3-4 times/week and 25-minute CBB training sessions 3-4 times a week.

There will be 3 assessments of participants: before and after the first 18-week period and then again after the second 18-week period. Assessments will be done in 2 sessions over a total of 90 minutes and will include demographic, health, physical activity and social activity questionnaires as well as the self-report measures of cognitive function, emotional state and weekly activities; quantitative assessments of physical balance, strength, flexibility blood pressure and heart rate; and tests of cognitive function. Subject medications will be recorded at each assessment. The wait-list control group will receive the same assessments at the same time points.

研究设计

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

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

  • Associated with Whitney center as residents or participants in non-resident programs.
  • Able to understand and read English.

排除标准

  • Not able to sit in a chair independently.
  • Not able to move both arms in simple movement sequence.
  • Hearing and vision insufficient to do the computer exercises or follow the PE instructions.
  • Not able to remember 3 movements in succession.

结局指标

主要结局

Composite cognition score

时间窗: 18 weeks

Composite from: Flanker Test of Attention; Go/No-Go Test of Response Inhibition; List Sort Working Memory Test; Logical Memory Story Recall; Digit symbol coding; Digit Span Forwards and Backwards; Hopkin's Verbal Learning Test; Trail Making B; Stroop Color Word; Category Verbal Fluency; Reaction Time. A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for each test for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.

Sit to Stand in one-minute

时间窗: 18 weeks

Number of times able to go from sit to stand in in one minute

Balance - stand on one foot at a time

时间窗: 18 weeks

Stand on one foot with the toe of the other foot touching the calf of the standing leg - number of seconds able to maintain. The sum of right and leg foot will be added.

Mood and Quality of Life

时间窗: 18 weeks

Composite score from WHODAS, DEMQ QLI and Beck Depression Inventory. A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for total score on each questionnaire for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.

次要结局

  • Attention and Speed of Processing(18 weeks)
  • Working Memory(18 weeks)
  • Verbal Memory(18 weeks)
  • Speed of Processing(18 weeks)
  • Cognitive Flexibility(18 weeks)
  • Response Inhibition(18 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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