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临床试验/NCT06322030
NCT06322030招募中不适用

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

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
99
试验地点
2
主要终点
Change in distance walk in 6 minute Walk Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The coordinator will not see group assignment, only a patient number which is entered into a software package.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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

研究组 & 干预措施

Diet

Experimental

15 week weight management program

干预措施: FOCUS-15 Lifestyle Management Program (Dietary Supplement)

Control

No Intervention

waitlist control

Exercise

Experimental

exercise training

干预措施: Exercise Training (Behavioral)

Diet + Exercise

Experimental

15 week weight management program + exercise training

干预措施: FOCUS-15 Lifestyle Management Program (Dietary Supplement)

Diet + Exercise

Experimental

15 week weight management program + exercise training

干预措施: Exercise Training (Behavioral)

结局指标

主要结局

Change in distance walk in 6 minute Walk Test

时间窗: approximately 15 weeks

Distance walk in 6 minutes

次要结局

  • Change in daily step activity(approximately 15 weeks)
  • Change in score of Inventory of Psychosocial Functioning (IPF)(approximately 15 weeks)
  • Change in score of Sheehan Disability Scale (SDS)(approximately 15 weeks)
  • Change in score of Stroke Impact Scale (SIS)(approximately 15 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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