Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Not Applicable

Completed

• Conditions: Cardiology; Nitric Oxide; Aging
• Interventions: Behavioral: Pedometer to Increase Physical Activity

• Registration Number: NCT01212978
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-01
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-10-01
• Primary Completion: 2013-07-01
• Study Completion: 2013-07-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pedometer + Motivational Software	Pedometer to Increase Physical Activity	In this arm, subjects will receive access to both a pedometer and motivational software
Pedometer only	Pedometer to Increase Physical Activity	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.

Primary Outcome Measures

Name	Time	Method
Flow induced Dilation of the Brachial Artery (FMD%)	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States