Clinical trial NCT01212978: Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis
Official title: Overcoming Inactivity in Older Adults: Impact on Vascular Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cardiology
Nitric Oxide
Keywords: Aging
Endothelium,Vascular
Arterial Remodeling
Ventricular Vascular Coupling
Nitric Oxide
Walking
Software
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2010-10-01
Enrollment: 114
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Flow induced Dilation of the Brachial Artery (FMD%)
timeFrame: 12 weeks
Secondary outcomes:
measure: Left Ventricular Systolic Performance
timeFrame: 12 weeks
measure: Left Ventricular Diastolic Function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Michael E Widlansky
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swartz AM, Cho CC, Welch WA, Widlansky ME, Maeda H, Strath SJ. Pattern Analysis of Sedentary Behavior Change after a Walking Intervention. Am J Health Behav. 2018 May 1;42(3):90-101. doi: 10.5993/AJHB.42.3.9.
citation: Suboc TB, Strath SJ, Dharmashankar K, Coulliard A, Miller N, Wang J, Tanner MJ, Widlansky ME. Relative importance of step count, intensity, and duration on physical activity's impact on vascular structure and function in previously sedentary older adults. J Am Heart Assoc. 2014 Feb 26;3(1):e000702. doi: 10.1161/JAHA.113.000702.