Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322030
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-13
Brief Title:
Weight Loss and ExeRcise
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Enhancing Mobility and Psychosocial Function in Obese Veterans Following Stroke Via Weight Loss and ExeRcise EMPOWER
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER
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 US 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RX004281 | OTHER_GRANT | None | None |
| PRO0120848 | OTHER | IRB Approval | None |