Stroke
Conditions
Keywords
obesity, weight loss, quality of life
Brief summary
Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke.
Detailed description
More than 2 million stroke survivors currently living in the U.S. are obese. Obesity is known to exacerbate age-related declines in function in these individuals and is associated with poorer clinical outcomes and quality of life. Weight-loss interventions are well-studied in neurologically healthy individuals and are shown to be effective for attenuating functional decline and improving quality of life. Despite these established benefits, there is currently an absence of studies investigating the effects of intentional weight loss on physical and/or psychosocial function in individuals following stroke. The investigators propose a trial aimed at Enhancing Mobility and Psychosocial function in Obese Veterans following stroke via Weight loss and ExeRcise (EMPOWER). This trial leverages a 15-week multidisciplinary approach to weight loss, via an existing lifestyle and weight management program, including caloric restriction, with or without concurrent supervised exercise training, as the catalyst by which remediation of physical and psychosocial impairments promote enhanced recovery in obese Veteran survivors of stroke. The investigators posit that successful weight loss will result in improvements in physical and psychosocial function (compared to control subjects) and that concurrent exercise will result in improved outcomes when compared to weight loss alone. The VHA 2010 Management of Stroke Rehabilitation Guidelines recommends that patients receive a formal rehabilitation assessment, the results of which should be used to determine the appropriate level of care and develop evidence-based interventions. However, without information regarding the effects of obesity and weight management on physical and psychosocial function as well as data on the long-term benefits of the program, evidence to guide decisions regarding the most appropriate approach to post-stroke rehabilitation for obese Veteran stroke survivors will remain elusive and recommendations for best available treatment cannot be met. Data from the proposed trial will have important clinical significance by determining the extent to which this type of program improves (or not) physical and psychosocial outcomes in Veterans following stroke and will provide a foundation for future studies aimed at establishing effectiveness of this approach to post-stroke care for Veterans.
Interventions
DIETARY_SUPPLEMENTFOCUS-15 Lifestyle Management Program
15 week weight management program
BEHAVIORALExercise Training
15 weeks of progressive exercise training
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The coordinator will not see group assignment, only a patient number which is entered into a software package.
Intervention model description
The investigators will utilize a 2x2 factorial design to assess for changes in our outcomes over time between treatment groups.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of stroke at least 6 months prior * BMI \> 30 kg/m2 * Residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34) * Ability to follow instructions, complete training and testing and to communicate exertion, pain and distress * Provision of informed consent * Individuals who meet inclusion criteria must complete an exercise tolerance test and be cleared for participation by the study cardiologist
Exclusion criteria
* Unable to ambulate at least 150 feet or experienced intermittent claudication while walking * Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's * Dementia * Life expectancy \<1 yr * History of DVT or pulmonary embolism within 6 months * Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions * Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest * Current enrollment in a rehabilitation trial to enhance motor or psychosocial recovery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in distance walk in 6 minute Walk Test | approximately 15 weeks | Distance walk in 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in daily step activity | approximately 15 weeks | Steps per day |
| Change in score of Stroke Impact Scale (SIS) | approximately 15 weeks | The 59 item SIS assesses post-stroke recovery in four psychosocial domains: social participation, emotion, communication, memory \& thinking; two motor domains: mobility \& strength, and overall activities of daily living as well as subjective extent of total recovery. Scores range from zero to 59, higher scores indicates better recovery. |
| Change in score of Sheehan Disability Scale (SDS) | approximately 15 weeks | The SDS is a brief, 3-item patient rated assessment of the degree of disability/impairment in work/school, social life, and family life/home responsibilities. Scores on the SDS range from zero (unimpaired) to 30 (highly impaired). |
| Change in score of Inventory of Psychosocial Functioning (IPF) | approximately 15 weeks | The IPF is an 80-item measure that more comprehensively indexes the domains assessed with the SDS but more finely resolves impairment. Each domain is scored from zero to 100 whither higher scores indicating higher impairment. |
Countries
United States
Contacts
CONTACTSarah A Jackson, BA MA
PRINCIPAL_INVESTIGATORChris M Gregory, PhD
Ralph H. Johnson VA Medical Center, Charleston, SC
Outcome results
None listed