IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT06322030 (EMPOWER) para Accidente cerebrovascular está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un ensayo coincide con los criterios de filtro
Vista de tarjeta
Weight Loss and ExeRcise (EMPOWER)
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06322030 (EMPOWER) es un ensayo intervencionista para Accidente cerebrovascular. Su estado actual es: reclutando. El ensayo se inició el 1 de mayo de 2024, con el objetivo de reclutar a 99 participantes. Dirigido por VA Office of Research and Development, se espera que finalice el 31 de marzo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de abril de 2025.
Resumen
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.
Descripción detallada
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.
Título oficial
Enhancing Mobility and Psychosocial Function in Obese Veterans Following Stroke Via Weight Loss and ExeRcise (EMPOWER)
Condiciones médicas
Accidente cerebrovascularOtros ID del ensayo
- EMPOWER
- N4281-R
- RX004281 (Otra financiación) (VA ORD RR&D)
- PRO0120848 (Otro identificador) (IRB Approval)
Número del NCT
Inicio del ensayo (real)
2024-05-01
Última actualización
2025-04-27
Fecha de finalización (estimada)
2028-03-31
Inscripción (prevista)
99
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
obesity
weight loss
quality of life
weight loss
quality of life
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalDiet 15 week weight management program | FOCUS-15 Lifestyle Management Program 15 week weight management program |
Sin intervenciónControl waitlist control | N/A |
ExperimentalExercise exercise training | Entrenamiento de ejercicio 15 weeks of progressive exercise training |
ExperimentalDiet + Exercise 15 week weight management program + exercise training | FOCUS-15 Lifestyle Management Program 15 week weight management program Entrenamiento de ejercicio 15 weeks of progressive exercise training |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in distance walk in 6 minute Walk Test | Distance walk in 6 minutes | approximately 15 weeks |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
40 Years
Criterios de sexo
Todos
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
- 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
Contactos centrales del ensayo
Contacto: Sarah A Jackson, BA MA, (843) 789-6700, [email protected]
1 Sitios del ensayo en 1 países
South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, 29401-5703, United States
R. Amanda C LaRue, PhD, Contacto, 843-789-6707, [email protected]
Thad Abrams, MD, Contacto, (319) 338-0581, [email protected]
Chris M Gregory, PhD, Investigador principal
Reclutando