Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders (SCIBHI)
2012年9月27日 更新者：University of South Florida
A Pilot Randomized Intervention Study of Physical Exercise and Social Engagement in Chinese Elders
A pilot randomized clinical trial was conducted in a random sample of 120 non-demented Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no intervention with respect to change in cognition and whole brain volume determined by repeated neuropsychological batteries and MRI scans.
Aims included determining the feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as well as collection of preliminary data on the efficacy of the interventions.
The long-term goal of this research program is to determine whether sustained physical and/or mental exercise interventions are efficacious in delaying the onset of dementia and to understand the role and mechanisms of brain growth in this process.
研究概览
地位
完全的
详细说明
Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly.
Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported.
A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks.
Two MRI's were obtained, one before the intervention period, the other after.
A neuropsychological battery was administered at baseline, 20 weeks and 40 weeks.
Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests.
Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models.
研究类型
介入性
注册 (实际的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Shanghai、中国
- Huashan Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 79年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- living in defined area
- either sex
- aged 60-79
Exclusion Criteria:
- history of stroke, Parkinson's disease or other neurologic disease
- inability to walk unassisted for two kilometers or maintain balance with feet side-by-side or semi-tandem for 10 seconds each
- education-adjusted Chinese Mini-Mental Examination score < 26 (to exclude individuals with dementia or moderate cognitive impairment
- cardiovascular or musculoskeletal conditions that would be contraindicated for the intervention programs
- contraindications for MRI
- diagnosis of any illness that would preclude participation in the full study
- regular vigorous exercise or Tai Chi practice.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Fast walking
Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route.
Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises.
Prior to the first session, each participant was given a pedometer with their name on it.
They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement.
At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded.
A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
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Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route.
Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises.
Prior to the first session, each participant was given a pedometer with their name on it.
They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement.
At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded.
A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
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有源比较器：Tai Chi
Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions.
Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
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Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions.
Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
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有源比较器：Intellectual stimulation
Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center.
Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
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Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center.
Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
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安慰剂比较：Contact and testing only
The fourth group received no intervention.
Contact was maintained by phone during the intervention period to reduce dropout.
Participants were called four times during the 40 weeks intervention period by the study coordinator.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in cognitive performance on battery of neuropsychological tests
大体时间：Baseline, 4 months, 8 months
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A comprehensive battery of neuropsychological tests was administered by a psychometrist.
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Baseline, 4 months, 8 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in whole brain volume
大体时间：Baseline, 8 months
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Structural MRIs were obtained at baseline and 8 months to provide data from which change in whole brain volume was determined.
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Baseline, 8 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：James A Mortimer, Ph.D.、University of South Florida
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年7月1日
初级完成 (实际的)
2009年9月1日
研究完成 (实际的)
2009年9月1日
研究注册日期
首次提交
2012年9月26日
首先提交符合 QC 标准的
2012年9月27日
首次发布 (估计)
2012年9月28日
研究记录更新
最后更新发布 (估计)
2012年9月28日
上次提交的符合 QC 标准的更新
2012年9月27日
最后验证
2012年9月1日
更多信息
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