Weight Loss and ExeRcise (EMPOWER)

Enhancing Mobility and Psychosocial Function in Obese Veterans Following Stroke Via Weight Loss and ExeRcise (EMPOWER)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Dietary supplement: FOCUS-15 Lifestyle Management Program; Behavioral: Exercise Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah A Jackson, BA MA; Phone Number: (843) 789-6700; Email: sarah.jackson@va.gov

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5703
      • Ralph H. Johnson VA Medical Center, Charleston, SC
      • Contact: R. Amanda C LaRue, PhD; Phone Number: 843-789-6707; Email: Rutha.Larue@va.gov
      • Contact: Thad Abrams, MD; Phone Number: 7618 (319) 338-0581; Email: thad.abrams@va.gov
      • Principal Investigator: Chris M Gregory, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet; 15 week weight management program	Dietary supplement: FOCUS-15 Lifestyle Management Program; 15 week weight management program; Other Names: Diet
No Intervention: Control; waitlist control
Experimental: Exercise; exercise training	Behavioral: Exercise Training; 15 weeks of progressive exercise training
Experimental: Diet + Exercise; 15 week weight management program + exercise training	Dietary supplement: FOCUS-15 Lifestyle Management Program; 15 week weight management program; Other Names: Diet; Behavioral: Exercise Training; 15 weeks of progressive exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in distance walk in 6 minute Walk Test	Distance walk in 6 minutes	approximately 15 weeks

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	Body composition	approximately 15 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Chris M Gregory, PhD, Ralph H. Johnson VA Medical Center, Charleston, SC

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; obesity; weight loss
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: N4281-R; RX004281 (Other Grant/Funding Number: VA ORD RR&D); PRO0120848 (Other Identifier: IRB Approval)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No