Wearable Technology to Reduce Sedentary Behavior and CVD Risk in Older Adults
2018年11月20日 更新者:University of Florida
This study will evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (NEPA).
研究概览
详细说明
A recruitment of 40 sedentary men and women ≥ 60 years of age with elevated cardiovascular risk and follow them for 20 weeks.
Participants will be randomly assigned (n = 20/group) to 1) an 8-week, twice-weekly, multi-modal, center-based exercise intervention (EX) followed by 12 additional weeks of follow-up assessment, or 2) the same intervention with participants also asked to wear a validated lightweight activity tracker on their hip during waking hours and instructed on how to reduce sedentary behavior increase NEPA within their daily routines (EX + NEPA).
Evaluations will be done to 1) the extent to which EX + NEPA modifies sedentary behavior, 2) the impact of the interventions on cardiovascular risk factors, including blood pressure, exercise capacity, waist circumference, and circulating biomarkers, and 3) develop and optimize study procedures to guide the future trial.
研究类型
介入性
注册 (实际的)
58
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
-
-
Florida
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Gainesville、Florida、美国、32611
- UF Clinical Translational Research Building
-
-
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
60年 及以上 (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:
- Sedentary lifestyle, defined as <150 min/wk of moderate physical activity by CHAMPS questionnaire
- Moderate to high-risk of CHD events according to ATP-III risk classification algorithm
- Willingness to be randomized to either intervention group
- Willingness to participate in all study procedures
Exclusion Criteria:
- Failure to provide informed consent;
- Regular participation in an exercise training program within the last 3 months
- Absolute contraindication(s) to exercise training (American College of Sports Medicine guidelines)
- Office SBP > 180 mm Hg or DBP > 110 mm Hg
- Severe cardiac disease, i.e. NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
- Myocardial infarction or stroke within past year
- Significant cognitive impairment, i.e. known dementia or a Mini-Mental State Examination score < 24
- Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, ALS;
- Severe rheumatologic/orthopedic disease, e.g., awaiting joint replacement, active inflammatory disease
- Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen;
- Hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
- Other significant co-morbid conditions that would impair ability to participate in the intervention
- Simultaneous participation in another intervention trial
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:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Exercise
This group will receive 8 weeks of center-based exercise followed by recommendations to remain physically active.
|
Center-based walking + balance, stretching, and light resistance
|
|
实验性的:Exercise + Non-Exercise Physical Activity (NEPA)
This group will receive 8 weeks of center-based exercise combined with behavioral counseling and a technology intervention designed to increase daily Exercise + Non-Exercise Physical Activity (NEPA).
|
Center-based walking + balance, stretching, and light resistance
Behavioral counseling paired with technology intervention to monitor physical activity
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Blood pressure between the groups
大体时间:20 weeks
|
20 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exercise capacity between the groups
大体时间:20 weeks
|
distance on 6-minute walk test
|
20 weeks
|
|
Waist circumference between the groups
大体时间:20 weeks
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20 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。
调查人员
- 首席研究员:Stephen Anton、Univesity of Florida
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4月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2018年11月20日
研究注册日期
首次提交
2015年12月14日
首先提交符合 QC 标准的
2015年12月14日
首次发布 (估计)
2015年12月16日
研究记录更新
最后更新发布 (实际的)
2018年11月23日
上次提交的符合 QC 标准的更新
2018年11月20日
最后验证
2018年11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.