Increasing Exercise and Decreasing Sedentary Behavior Among Patients in a Cardiac Rehabilitation Clinic
2017年9月1日 更新者:Andrew Busch、The Miriam Hospital
Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not attending rehabilitation and there is a steep drop off in exercise following rehabilitation completion.
Moreover, little is known about the amount of time that cardiac rehabilitation patients spend in sedentary behavior, which is associated with increased risk of cardiovascular morbidity and mortality, independent of time spent in exercise.
This pilot study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity physical activity accumulated in bouts of at least 10 minutes in duration (i.e.
bout-related MVPA) and decrease time spent in sedentary behavior.
Up to 32 patients will be recruited, enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1) B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone.
Participants will complete 7 days of objective activity monitoring to measure daily minutes spent in bout-related MVPA and sedentary behavior (primary outcomes) at baseline, mid-rehabilitation (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up (16 weeks).
At these same time points, participants will complete questionnaires assessing sedentary behavior, MVPA, exercise tolerance, health-related quality of life, mood, and affect.
At baseline and end of cardiac rehabilitation participants will undergo a blood draw to measure cardiometabolic and inflammatory risk factors and complete a test of cognitive functioning.
Feasibility and acceptability of the B-MOBILE-CARDIAC application will be assessed at the 4-week follow-up.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
23
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
-
-
Rhode Island
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Providence、Rhode Island、美国、02903
- The Miriam 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
18年 至 75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:
- within one week of starting rehabilitation,
- self-report that they can walk for 10 minutes without assistance from others,
- were approved for and are planning to complete 12 weeks of rehabilitation,
- own a compatible Android phone or are willing to be taught to use one by study staff;
- no evidence of cognitive impairment
- able to speak and read English,
- aged 18-75 years,
- no known nickel allergy, and
- willing to follow the protocol (e.g., carry a smartphone for 16 weeks).
Exclusion Criteria:
-
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:并行分配
- 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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其他:Cardiac rehabilitation as usual
Participants will receive cardiac rehabilitation as usual (i.e., as offered in the clinical setting).
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实验性的:Cardiac rehabilitation plus B-MOBILE-CARDIAC smartphone app
Participants will receive cardiac rehabilitation as usual, plus access to the B-MOBILE-CARDIAC smartphone application through 4 weeks post-rehabilitation.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in objectively measured time engaged in sedentary behavior
大体时间:Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
大体时间:Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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Change from Baseline to 12 weeks (i.e., end of rehabilitation)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Self-reported sedentary behavior (The Sedentary Behavior Questionnaire)
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported sedentary behavior (SIT-Q-7d Questionnaire)
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported physical activity (Paffenbarger Physical Activity Questionnaire)
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Self-reported exercise tolerance (Duke activity status index)
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Health related quality of life (SF-12 Health Survey)
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Depressed Mood (Patient Health Questionnaire-9)
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Affect (Positive Affect Negative Affect Scales)
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Cognitive status (Montreal Cognitive Assessment score)
大体时间:Baseline and 12 weeks (i.e., end of rehabilitation).
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Baseline and 12 weeks (i.e., end of rehabilitation).
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Smartphone application acceptability (study specific scale)
大体时间:Baseline through 16 weeks.
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Baseline through 16 weeks.
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Change in objectively measured time engaged in sedentary behavior
大体时间:Change from Baseline to 16 weeks
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Change from Baseline to 16 weeks
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Change in objectively measured time engaged in moderate-to-vigorous intensity physical activity
大体时间:Change from Baseline to 16 weeks
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Change from Baseline to 16 weeks
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Lipid profile
大体时间:Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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C-reactive protein
大体时间:Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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haemoglobin A1c (HbA1C)
大体时间:Baseline and 12 weeks (i.e., end of rehabilitation)
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Baseline and 12 weeks (i.e., end of rehabilitation)
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Blood pressure
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Waist circumference
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Body Mass Index (kg/m^2, weight in kilograms, height in meters)
大体时间:Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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Baseline, 6 weeks, 12 weeks (i.e., end of rehabilitation), and 16 weeks.
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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
2016年3月1日
初级完成 (实际的)
2017年4月1日
研究完成 (实际的)
2017年4月1日
研究注册日期
首次提交
2016年2月2日
首先提交符合 QC 标准的
2016年2月5日
首次发布 (估计)
2016年2月10日
研究记录更新
最后更新发布 (实际的)
2017年9月6日
上次提交的符合 QC 标准的更新
2017年9月1日
最后验证
2017年9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.