Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Completed

CT.gov ID

NCT01212978

Collaborator

American Heart Association (Other)

114

Enrollment

Location

Arms

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aging Cardiology Nitric Oxide	Behavioral: Pedometer to Increase Physical Activity	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Actual Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Delayed Intervention These subjects will neither receive a pedometer or access to the motivational software until completion of the study.
Active Comparator: 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.	Behavioral: 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. Other Names: Omron Pocket Pedometer
Experimental: Pedometer + Motivational Software In this arm, subjects will receive access to both a pedometer and motivational software	Behavioral: 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. Other Names: Omron Pocket Pedometer

Arm

Intervention/Treatment

No Intervention: Delayed Intervention

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

Active Comparator: 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.

Behavioral: 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.

Other Names:

Omron Pocket Pedometer

Experimental: Pedometer + Motivational Software

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

Behavioral: 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.

Other Names:

Omron Pocket Pedometer

Outcome Measures

Primary Outcome Measures

Flow induced Dilation of the Brachial Artery (FMD%) [12 weeks]

Secondary Outcome Measures

Left Ventricular Systolic Performance [12 weeks]
Ventricular systolic stiffness and arterial elastance
Left Ventricular Diastolic Function [12 weeks]
Use of multiple echocardiographic parameters to measure

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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