Study for Rural Innovations in the Delivery of Exercise (STRIDE)
2021年5月5日 更新者：Kushang Patel、University of Washington
Adapting an Evidence-Based Exercise Program for Remote Delivery to Rural Older Adults
: Falls are the primary cause of injury and a leading cause of disability and mortality among older adults.
Risk factors for falling are common among older adults with knee osteoarthritis (OA) - a highly prevalent condition.
Physical exercise is consistently the most efficacious intervention for preventing falls in older adults.
However, access to these programs is severely limited in rural settings.
Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA.
Accordingly, the proposed project aims to refine a protocol for remote delivery of Enhance Fitness (EF).
EF is an evidence-based, group exercise program involving strength, endurance, and balance training that is recommended for falls prevention and OA management
研究概览
研究类型
介入性
注册 (实际的)
15
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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Washington
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Seattle、Washington、美国、98195-6540
- University of Washington
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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
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Community-dwelling
- English-speaking
- Physician diagnosed knee osteoarthritis
- Knee pain that occurs almost daily for at least the past 3 months and is moderate to severe in intensity
- Knee pain-related difficulty with walking or climbing stairs
- resident of a rural county
Exclusion Criteria:
- cognitive impairment determined by a Mini Montreal Cognitive Assessment score of <11
- any of the following in the past 6 months: cancer requiring treatment (except for non- melanoma skin cancer), heart attack, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus; and temporary exclusions
- hospitalization within the last month
- ≥3 falls within the past month
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：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Tele-EF
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
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Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
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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 |
|---|---|---|
|
Feasibility and Acceptability of Tele-Enhance Fitness
大体时间：12 weeks
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Feasibility outcomes include intervention engagement and adherence, retention, fidelity of tele-EF treatment, and adverse events.
Multiple dimensions of acceptability will be assessed from qualitative interviews with participants and instructors.
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12 weeks
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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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Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
大体时间：Change from baseline PROMIS physical function score at 12 weeks
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Patient-reported physical functioning
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Change from baseline PROMIS physical function score at 12 weeks
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膝关节损伤和骨关节炎结果评分 (KOOS) 身体功能分量表
大体时间：12 周时基线 KOOS 身体功能子量表评分的变化
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患者报告的膝关节疼痛相关的身体机能干扰
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12 周时基线 KOOS 身体功能子量表评分的变化
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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。
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1月1日
初级完成 (预期的)
2021年8月1日
研究完成 (预期的)
2021年8月1日
研究注册日期
首次提交
2021年5月5日
首先提交符合 QC 标准的
2021年5月5日
首次发布 (实际的)
2021年5月11日
研究记录更新
最后更新发布 (实际的)
2021年5月11日
上次提交的符合 QC 标准的更新
2021年5月5日
最后验证
2021年5月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The investigators recognize that data sharing leads to the promotion of science.
We intend to publish the results of the proposed study and will make data available to investigators upon request (following publication).
The final dataset will include demographic, clinical, and behavioral data on 15 older adults followed over a 3-month period.
Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the possibility of deductive disclosure of subjects with unusual characteristics remains.
For these reasons, we propose to make the data and associated documentation available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
膝骨性关节炎的临床试验
Tele-Enhance Fitness的临床试验
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Pennington Biomedical Research CenterAmerican Diabetes Association; Louisiana State University, Baton Rouge; American Council on Exercise完全的
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University of British ColumbiaUniversity of Utah; University of Virginia未知
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Catholic University of the Sacred HeartFondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione I.R.C.C.S. Istituto...邀请报名
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Centre Hospitalier Universitaire de Saint Etienne完全的
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Northwestern UniversityEmory University完全的