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临床试验/NCT01212978
NCT01212978已完成不适用

Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
Flow induced Dilation of the Brachial Artery (FMD%)

研究概览

简要总结

The American Heart Association (AHA) and American College of Sports Medicine (ASCM) recommend older adults (50≤ age ≤ 80) perform at least 30 minutes of moderate-intensity aerobic exercise on most days ( ≥5 days) of the week. This suggestion arises, in part, from data supporting that regular physical activity reduces the risk of adverse cardiovascular events A portion of these benefits may be from reductions in the incidence and severity of cardiovascular risk factors, including diabetes mellitus, obesity, and hypertension.

While this recommendation for physical activity has been in existence for almost 15 years, the rates of obesity in the United States continue to rise and prevalence of sedentarism remains at best unchanged. Researchers have been engaged in investigating novel interventions to designed increase physical activity to reach the recommended activity targets. One promising intervention involves use of inexpensive, easy to use pedometers that allow individuals to objectively track the number of steps taken during a set period of time. Recent data suggest that an average of 10,000 steps/day as measured by a pedometer accurately estimates the activity levels recommended by the AHA, ASCM, and US government public health guidelines.

While the benefits of habitual exercise are well-documented, there are no data that demonstrate current recommendations for moderate physical activity in older adults by the ASCM, AHA, and US public health guidelines reduce the risk of adverse cardiovascular events. Interestingly, prior work indicates that pedometer-centered interventions can increase physical activity, suggesting that this type of intervention could potentially lead to cardiovascular benefits. Using validated surrogate markers of cardiovascular risk including brachial artery endothelial function, tonometric measurements of vascular stiffness, and measurements derived from transthoracic echocardiography, we will determine whether increasing the physical activity of sedentary adults to an average of 10,000 steps or more/day translates into improvements in cardiovascular health. This will be determined in the context of a randomized control trial employing a control group, a study group that uses a pedometer alone, and an intervention that couples a pedometer with internet-based motivational messaging software demonstrated in our preliminary data to encourage older adults to reach and exceed the 10,000 steps/day goal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 50 and ≤90 years of age
  • Able to Ambulate without an Assist Device

排除标准

  • History of Uncontrolled Diabetes Mellitus (Type 1 or 2) HgA1C >9.0%
  • Uncontrolled hypertension with a blood pressure greater than 160/100 mmHg at the screening visit.
  • Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
  • Known history of cognitive impairment or inability to follow study procedures
  • History of limb amputation other than toes
  • History or Reynaud's Disease
  • Unable to button a shirt or blouse
  • Pregnancy

研究组 & 干预措施

Delayed Intervention

No Intervention

These subjects will neither receive a pedometer or access to the motivational software until completion of the study.

Pedometer only

Active Comparator

Participants in the this arm will receive a pedometer with instructions to reach a goal of 10,000 steps/day but will not receive access to the motivational software.

干预措施: Pedometer to Increase Physical Activity (Behavioral)

Pedometer + Motivational Software

Experimental

In this arm, subjects will receive access to both a pedometer and motivational software

干预措施: Pedometer to Increase Physical Activity (Behavioral)

结局指标

主要结局

Flow induced Dilation of the Brachial Artery (FMD%)

时间窗: 12 weeks

次要结局

  • Left Ventricular Systolic Performance(12 weeks)
  • Left Ventricular Diastolic Function(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael E. Widlansky

Assistant Professor of Medicine

Medical College of Wisconsin

研究点 (2)

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