Identifying and Treating Physical Function Impairment in Elders
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.
Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.
Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.
Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.
Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Anschutz Medical Campus
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)
Exclusion Criteria:
- Inability to walk ≥30 feet without human assistance7
- Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
- Severe vision loss (legally blind)
- Severe hearing loss
- Medical condition that precludes increasing physical activity per primary care provider's assessment
- Terminal diagnosis per primary care provider's assessment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 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:Behavioral Intervention
Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers
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无干预:Usual Care
Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic).
No behavioral counseling.
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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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Changes in physical activity as determined by accelerometer
大体时间:12 weeks
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Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.
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12 weeks
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Changes in physical function as assessed by 400-meter walk speed
大体时间:12 weeks
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Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.
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12 weeks
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Changes in physical function as assessed by Short Physical Performance Battery
大体时间:12 weeks
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Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention
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12 weeks
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Change in physical function as assessed by lower extremity strength testing
大体时间:12 weeks
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Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .
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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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Evaluation of standard implementation science process of reach
大体时间:1 year
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Reach is the percent of patients consented divided by the number eligible.
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1 year
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Assessment of standard implementation science process metrics of acceptability
大体时间:1 year
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Acceptability will be assessed through structured surveys.
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1 year
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Assessment of standard implementation science process metrics of implementation
大体时间:1 year
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Implementation process will be assessed by structured surveys
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1 year
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合作者和调查者
调查人员
- 首席研究员:Amy Huebschmann, MD、University of Colorado - Anschutz Medical Campus
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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