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Completed

NCT Number: NCT01212978

Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Pedometer to Increase Physical Activity

Behavioral

The pedometer will be given to arms 2 and 3 (pedometer only and pedometer+software intervention) to help them guide their increase in physical activity.

Other names: Omron Pocket Pedometer

Primary outcomes

  1. Flow induced Dilation of the Brachial Artery (FMD%)

    Time frame: 12 weeks

Secondary outcomes

  1. Left Ventricular Systolic Performance

    Time frame: 12 weeks

    Ventricular systolic stiffness and arterial elastance

  2. Left Ventricular Diastolic Function

    Time frame: 12 weeks

    Use of multiple echocardiographic parameters to measure

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 1, 2010
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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