Weight Loss and ExeRcise

Stroke Clinical Trial

— EMPOWER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322030
• Other study ID #: N4281-R
• Secondary ID: RX004281PRO01208
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Sarah A Jackson, BA MA
• Phone: (843) 789-6700
• Email: sarah.jackson[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: March 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Weight Loss

Intervention

Dietary Supplement:
• FOCUS-15 Lifestyle Management Program
15 week weight management program

Behavioral:
• Exercise Training
15 weeks of progressive exercise training

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood lipid profile	The investigators will measure fasting glucose, triglycerides, and cholesterol (total, LDL and HDL)	approximately 15 weeks
Other	Change in body composition in Dual-energy x-ray absorptiometry	Body composition	approximately 15 weeks
Primary	Change in distance walk in 6 minute Walk Test	Distance walk in 6 minutes	approximately 15 weeks
Secondary	Change in daily step activity	Steps per day	approximately 15 weeks
Secondary	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
Secondary	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
Secondary	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