Health Promotion and Wellness Program for Stroke Survivors



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 75
Updated:7/14/2016
Start Date:January 2013
End Date:July 2017
Contact:Corey McDaniel, BS
Email:Corey.McDaniel@UHHospitals.org
Phone:(216) 368-4879

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Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors

The objective of this study is to conduct a randomized controlled pilot study to examine the
efficacy, feasibility and safety of the SystemCHANGE™ health promotion and wellness program
in stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ program
will help overweight and obese stroke survivors engaging in healthy behaviors, thereby
improving health and function.

Over 60% of stroke survivors are either overweight or obese, and a projected 4.98 million
stroke survivors have multiple cardiovascular risk factors. Stroke survivors are at
significant risk for de-conditioning, elevated inflammatory markers, and insulin resistance,
which subsequently increases risk for secondary stroke and cardiovascular disease. Engaging
in healthy behaviors, such as physical activity, good sleep hygiene, and nutrition, to
facilitate energy balance may help reduce the risk of secondary conditions and ultimately
improve physical function and quality of life in stroke survivors. Thus, the specific study
aims are to engage potential participants (i.e., stroke survivors) and their families as
co-designers to adapt the SystemCHANGE™ comprehensive lifestyle intervention, and then
conduct a randomized controlled pilot study to provide preliminary estimates of the
intervention's efficacy in 35 stroke survivors.

Inclusion Criteria:

- physician-confirmed unilateral ischemic or hemorrhagic stroke

- at least 6 weeks post-stroke

- physician consent to participate

- BMI between 25 to 40 kg/m2

- stable weight for the past 4 weeks

Exclusion Criteria:

- heart disease (i.e., myocardial infarction, congestive heart failure, coronary artery
bypass grafting or valve replacement during the past 3 months, serious cardiac
arrhythmias, hypertrophic cardiomyopathy, and severe aortic stenosis)

- pulmonary embolus,

- uncontrolled blood pressure (i.e., 140/90 mmHg) or diabetes (fasting blood sugar
levels > 125 mg/dl)

- unable to communicate

- severe cognitive deficits

- pregnancy

- three or more falls in the past month,

- inability to walk 3 meters with or without a mobility device,

- weight loss medications or medications that cause weight gain (i.e., corticosteroids
and antipsychotic),

- gastric bypass surgery
We found this trial at
1
site
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Matthew A Plow, Ph.D
Phone: 216-368-4879
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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