Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2013-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Aging Cardiology Nitric Oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Delayed Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Pedometer only

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.

Group Type ACTIVE_COMPARATOR

Pedometer to Increase Physical Activity

Intervention Type 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.

Pedometer + Motivational Software

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

Group Type EXPERIMENTAL

Pedometer to Increase Physical Activity

Intervention Type 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.

Interventions

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Pedometer to Increase Physical Activity

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Omron Pocket Pedometer

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes