Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Aging Clinical Trial

Official title:

Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212978
• Other study ID #: MCW-MEW2
• Secondary ID: 10GRNT3880044
• Status: Completed
• Phase: N/A
• Start date: September 1, 2010
• Est. completion date: July 1, 2013

Study information

• Verified date: February 2019
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 1, 2013
• Est. primary completion date: July 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cardiology
• Nitric Oxide

Intervention

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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow induced Dilation of the Brachial Artery (FMD%)		12 weeks
Secondary	Left Ventricular Systolic Performance	Ventricular systolic stiffness and arterial elastance	12 weeks
Secondary	Left Ventricular Diastolic Function	Use of multiple echocardiographic parameters to measure	12 weeks

External Links

•   Link to information on physical activity studies