Clinical trial NCT06322030: Weight Loss and ExeRcise
Official title: Enhancing Mobility and Psychosocial Function in Obese Veterans Following Stroke Via Weight Loss and ExeRcise (EMPOWER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: obesity
weight loss
quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-03-20
Enrollment: 99
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will utilize a 2x2 factorial design to assess for changes in our outcomes over time between treatment groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in distance walk in 6 minute Walk Test
timeFrame: approximately 15 weeks
Secondary outcomes:
measure: Change in daily step activity
timeFrame: approximately 15 weeks
measure: Change in score of Stroke Impact Scale (SIS)
timeFrame: approximately 15 weeks
measure: Change in score of Sheehan Disability Scale (SDS)
timeFrame: approximately 15 weeks
measure: Change in score of Inventory of Psychosocial Functioning (IPF)
timeFrame: approximately 15 weeks
Other outcomes:
measure: Change in blood lipid profile
timeFrame: approximately 15 weeks
measure: Change in body composition in Dual-energy x-ray absorptiometry
timeFrame: approximately 15 weeks
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Chris M Gregory, PhD
role: PRINCIPAL_INVESTIGATOR
References: