Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01212978
Study type	Interventional
Source	Medical College of Wisconsin
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2010
Completion date	July 1, 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.