促进老年拉丁裔认知健康、心血管健康和睡眠的身体活动干预
2026年4月27日 更新者：Gloria Adriana Perez、University of Pennsylvania
本研究是一项随机、单盲、对照试验，将测试旨在促进中等强度身体活动的多层次干预 Tiempo Juntos para la Salud（健康时光）；有理论依据的调解人；心血管健康、睡眠和认知功能的次要结果。
参与者将在一年的时间里进行 4 次访问。
数据收集将在基线、3 个月、6 个月和 12 个月时在 216 名年龄在 55 岁及以上且有轻度认知障碍 (MCI) [蒙特利尔认知评估 (MoCA) 评分为 23 至 26 分的拉丁裔人群] 的西班牙裔拉丁裔中进行。
研究概览
研究类型
介入性
注册 (实际的)
234
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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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania School of Nursing
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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
51年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 可以提供知情同意
- 55 岁以上
- 自我认同为西班牙裔/拉丁裔
- 西班牙语为主要语言
- 愿意参加干预/教育会议
- 访问电话/手机
- 每周活动少于 150 分钟（久坐）
- 蒙特利尔认知评估 (MoCA) 评分（拉丁裔人群评分 ≥ 23 至 26）
排除标准：
- 无法提供知情同意
- 行动不便
- 肌肉骨骼问题/合并症（防止中度 PA）
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Tiempo Juntos 干预
如果分配到该组，参与者将每周参加两次 1 小时的小组会议，持续 3 个月。
这些课程将由训练有素的社区卫生工作者进行，包括小组（5-6 名参与者）中等强度的步行。
它们将在所有参与者都可以参加的时间在社区合作伙伴站点举行。
在恶劣天气的情况下，可通过社区合作伙伴获得室内位置。
步行将反映参与者的目标和能力，最初持续 10 分钟，包括 5 分钟的伸展“热身”和 5 分钟的“放松”练习，总共 20 分钟。
步行持续时间将增加 5 分钟/周，达到至少 30 分钟，同时减少节目内容交付时间，以适应 1 小时课程中增加的步行时间。
在完成 3 个月的身体活动课程后，在接下来的 3 个月中，他们将每隔一周通过电话/短信接收一次激励性“助推器”课程。
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如果分配到该组，参与者将每周参加两次 1 小时的小组会议，持续 3 个月。
这些课程将由训练有素的社区卫生工作者进行，包括小组（5-6 名参与者）中等强度的步行。
在完成 3 个月的身体活动课程后，在接下来的 3 个月中，他们将每隔一周通过电话/短信接收一次激励性“助推器”课程。
|
|
无干预：注意力控制
如果分配到该组，参与者将参加每周两次的 1 小时组（5-6 名参与者）课程，持续 3 个月。
这些会议将由受过培训的社区卫生工作者或合格的工作人员主持，他们将涉及用西班牙语审查与成人健康相关的教育主题。
它们将在所有参与者都可以参加的时间在社区合作伙伴站点或远程进行。
在恶劣天气的情况下，室内位置或远程选项将可用。
完成 3 个月的教育课程后，在接下来的 3 个月中，他们将通过电话/短信接收每隔一周提供的教育“助推器”课程。
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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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3 个月时基线身体活动频率的变化
大体时间：12周
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活动场数
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12周
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6 个月时基线身体活动频率的变化
大体时间：24周
|
活动场数
|
24周
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12 个月时基线身体活动频率的变化
大体时间：48周
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活动场数
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48周
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3 个月时基线体力活动强度的变化
大体时间：12周
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轻度、中度或剧烈（由每分钟计数决定）
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12周
|
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6 个月时基线体力活动强度的变化
大体时间：24周
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轻度、中度或剧烈（由每分钟计数决定）
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24周
|
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12 个月时基线体力活动强度的变化
大体时间：48周
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轻度、中度或剧烈（由每分钟计数决定）
|
48周
|
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3 个月时基线体力活动持续时间的变化
大体时间：12周
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活动总时间（小时和分钟）
|
12周
|
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6 个月时基线体力活动持续时间的变化
大体时间：24周
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活动总时间（小时和分钟）
|
24周
|
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12 个月时基线体力活动持续时间的变化
大体时间：48周
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活动总时间（小时和分钟）
|
48周
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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。
调查人员
- 首席研究员：Gloria A Perez, PhD, CRNP、University of Pennsylvania
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。
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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 (实际的)
2021年8月27日
初级完成 (实际的)
2025年12月31日
研究完成 (实际的)
2025年12月31日
研究注册日期
首次提交
2021年7月30日
首先提交符合 QC 标准的
2021年8月26日
首次发布 (实际的)
2021年9月1日
研究记录更新
最后更新发布 (实际的)
2026年5月1日
上次提交的符合 QC 标准的更新
2026年4月27日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.