Physical Activity Behavior Change for Older Adults After Dysvascular Amputation (PABC)
2020年2月6日 更新者：VA Office of Research and Development
Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change.
The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation.
This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.
研究概览
地位
完全的
详细说明
This pilot study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with dysvascular lower limb amputation. In addition, preliminary efficacy of the PABC intervention will be assessed using a two-group randomized cross-over design. Testing will occur at baseline (pre-intervention), three months (end of intervention), and six months. The primary aim is to determine feasibility of using the PABC intervention with Veterans who have dysvascular amputation by measuring:
- participant retention
- dose goal attainment
- participant acceptability
- safety The secondary aim is to preliminary assess efficacy of the PABC intervention by measuring accelerometer-based physical activity and self-report disability effect sizes.
研究类型
介入性
注册 (实际的)
31
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
-
-
Colorado
-
Aurora、Colorado、美国、80045
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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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
50年 至 85年 (成人、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:
- Lower limb amputation 1-5 years prior to enrollment
- Type 2 Diabetes Mellitus and/or
- Peripheral Artery Disease
- Ambulatory using a lower limb prosthesis
- English speaking
Exclusion Criteria:
- Traumatic or cancer-related etiology of the lower limb amputation
Unstable heart condition, including:
- unstable angina
- uncontrolled cardiac dysrhythmia
- acute myocarditis
- acute pericarditis
- Uncontrolled hypertension
- Acute systemic infection
- Prisoner
- Decisionally challenged volunteers
- Cancer
- Recent cerebral vascular accident (within two years)
- lower extremity wound or ulcer that limits ability to ambulate
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：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Early PABC Intervention
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months.
GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
|
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity.
Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist.
Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity.
Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist.
Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning
|
|
实验性的：Wait-List Control Intervention
GROUP 2 will participate in a non-exercise control phase during the first 3 months.
GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
|
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity.
Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist.
Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity.
Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist.
Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning
|
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 |
|---|---|---|
|
Retention Rate
大体时间：3 months
|
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
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3 months
|
|
Dose Goal Attainment
大体时间：3 months
|
Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps.
|
3 months
|
|
Acceptability
大体时间：3 months
|
Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale.
The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0.
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3 months
|
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Study-Related Adverse Events
大体时间：3 months
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Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Accelerometer-Based Physical Activity
大体时间：3 months
|
Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph).
The outcome will be average daily physical activity counts.
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3 months
|
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Late Life Function and Disability Scale, Frequency
大体时间：3 months
|
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Scores range from 0 to 100, with higher scores indicating higher disability.
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3 months
|
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Accelerometer-Based Physical Activity
大体时间：6 months
|
Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph).
The outcome will be average daily physical activity counts.
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6 months
|
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Late Life Function and Disability Scale, Frequency
大体时间：6 months
|
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Scores range from 0 to 100, with higher scores indicating higher disability.
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6 months
|
|
Late Life Function and Disability Scale, Limitation
大体时间：3 months
|
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Scores range from 0 to 100, with higher scores indicating higher disability.
|
3 months
|
|
Late Life Function and Disability Scale, Limitation
大体时间：6 months
|
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Scores range from 0 to 100, with higher scores indicating higher disability.
|
6 months
|
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。
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 (实际的)
2016年7月1日
初级完成 (实际的)
2019年2月22日
研究完成 (实际的)
2019年2月22日
研究注册日期
首次提交
2016年3月16日
首先提交符合 QC 标准的
2016年4月8日
首次发布 (估计)
2016年4月14日
研究记录更新
最后更新发布 (实际的)
2020年2月18日
上次提交的符合 QC 标准的更新
2020年2月6日
最后验证
2020年2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.