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| ID | Type | Description | Link |
|---|---|---|---|
| RX004281 | Other Grant/Funding Number | VA ORD RR&D | |
| PRO0120848 | Other Identifier | IRB Approval |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet | Experimental | 15 week weight management program |
|
| Control | No Intervention | waitlist control | |
| Exercise | Experimental | exercise training |
|
| Diet + Exercise | Experimental | 15 week weight management program + exercise training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOCUS-15 Lifestyle Management Program | Dietary Supplement | 15 week weight management program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in distance walk in 6 minute Walk Test | Distance walk in 6 minutes | approximately 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in daily step activity | Steps per day | approximately 15 weeks |
| Change in score of Stroke Impact Scale (SIS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood lipid profile | The investigators will measure fasting glucose, triglycerides, and cholesterol (total, LDL and HDL) | approximately 15 weeks |
| Change in body composition in Dual-energy x-ray absorptiometry |
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah A Jackson, BA MA | Contact | (843) 789-6700 | sarah.jackson@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Chris M Gregory, PhD | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Recruiting | Charleston | South Carolina | 29401-5703 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
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The investigators will utilize a 2x2 factorial design to assess for changes in our outcomes over time between treatment groups.
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The coordinator will not see group assignment, only a patient number which is entered into a software package.
| Exercise Training | Behavioral | 15 weeks of progressive exercise training |
|
| approximately 15 weeks |
| Change in score of Sheehan Disability Scale (SDS) | 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). | approximately 15 weeks |
| Change in score of Inventory of Psychosocial Functioning (IPF) | 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. | approximately 15 weeks |
Body composition
| approximately 15 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |