Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Michael E. Widlansky, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01212978
First received: September 29, 2010
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention
Aging
Cardiology
Nitric Oxide
Behavioral: Pedometer to Increase Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Flow induced Dilation of the Brachial Artery (FMD%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Left Ventricular Systolic Performance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Ventricular systolic stiffness and arterial elastance

  • Left Ventricular Diastolic Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Use of multiple echocardiographic parameters to measure


Enrollment: 114
Study Start Date: September 2010
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Omron Pocket Pedometer

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212978

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
American Heart Association
Investigators
Principal Investigator: Michael E Widlansky Medical College of Wisconsin
  More Information

Additional Information:
No publications provided

Responsible Party: Michael E. Widlansky, Assistant Professor of Medicine, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01212978     History of Changes
Other Study ID Numbers: MCW-MEW2, 10GRNT3880044
Study First Received: September 29, 2010
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Aging
Endothelium,Vascular
Arterial Remodeling
Ventricular Vascular Coupling
Nitric Oxide
Walking
Software

ClinicalTrials.gov processed this record on April 16, 2014