权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Improving health self-management using walking biobehavioral intervention for people with dysvascular lower limb amputation

通过步行生物行为干预改善下肢血管障碍截肢患者的健康自我管理

基本信息

批准号：
10614536
负责人：
Cory L Christiansen
金额：
$ 38.51万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10614536
关键词：
2 arm randomized control trial Address Adoption Ambulatory Care Amputation Behavior Caring Chronic Chronic Disease Clinical Clinical Research Complex Control Groups Diabetes Mellitus Disabled Persons Disease Early Intervention Enrollment Environment Evaluation Focus Groups Funding Opportunities Futility Future Goals Guidelines Health Intervention Learning Lower Extremity Maintenance Measures Medical Methods Monitor Motivation Nature Outcome Participant Patient Recruitments Patients Peripheral arterial disease Persons Phase Phase II Clinical Trials Physical Function Physical activity Population Prosthesis Prosthetic rehabilitation Quality of life Questionnaires Reach, Effectiveness, Adoption, Implementation, and Maintenance Recovery Rehabilitation therapy Reporting Research Research Design Role Schedule Self Efficacy Self Management Site Testing Time Training Traumatic Amputation Treatment Efficacy United States National Institutes of Health Walking Work World Health Organization attentional control biobehavior clinical implementation comorbidity comparison control design disability eligible participant evidence base healing implementation design implementation evaluation improved limb amputation limb loss multiple chronic conditions novel patient oriented phase III trial physical conditioning prevent primary endpoint primary outcome rural area sedentary lifestyle success telehealth underserved area wearable sensor technology

项目摘要

PROJECT SUMMARY / ABSTRACT The ultimate goal of this line of research is to optimize quality of life and minimize disability for people with dysvascular lower limb amputation through improved physical activity self-management. An initial step toward that goal is to test our walking biobehavioral intervention. Our overarching hypothesis is that implementing walking biobehavioral intervention for people recovering from dysvascular lower limb amputation, a disease characterized by multiple chronic conditions, will improve health self-management, as measured by increased habitual physical activity. The complex, comorbid nature of dysvascular amputation requires extended healing time and unique approaches to recovery compared to amputation from traumatic causes. Chronic sedentary behaviors that are present before amputation become more obvious when compounded by the effects of limb loss. As a result, people with dysvascular amputation report extremely high disability and walking limitation as their number one functional problem. Biobehavioral intervention integrated within conventional prosthesis rehabilitation is an opportune time to address walking behaviors by capitalizing on motivation for change. However, prosthetic training guidelines do not include walking biobehavioral intervention. Therefore, the purposes of this Phase II clinical trial are to: 1) test the benefit of walking biobehavioral intervention for improving habitual daily walking activity and 2) determine the potential for implementing the walking biobehavioral intervention in rehabilitation by performing initial assessments of intervention reach, efficacy, adoption, implementation, and maintenance. This trial presents an alternative strategy for improving quality of life and reducing disability in an underserved, medically complex, chronic disease population. The trial is directly aligned with the NIH Funding Opportunity Announcement PA-18-146, which seeks clinical research on self-management interventions that improve quality of life in persons needing assistance to optimize function, prevent/delay disability, and navigate their environment.

项目总结/摘要这项研究的最终目标是优化人们的生活质量，最大限度地减少残疾。通过改善体力活动自我管理，初始实现这一目标步骤是测试我们的步行生物行为干预。我们的首要假设是对下肢血管障碍性截肢康复者实施步行生物行为干预，一种以多种慢性疾病为特征的疾病，将改善健康自我管理，增加习惯性体力活动。复杂的，共病的性质，血管障碍截肢需要与创伤性截肢相比，愈合时间延长，恢复方法独特。截肢前存在的慢性久坐行为在以下情况下变得更加明显：失去肢体的影响因此，患有血管障碍性截肢的人报告残疾率极高，行走受限是他们的头号功能问题。生物行为干预传统的假肢康复是一个适当的时机，以解决步行行为，变革的动力。然而，假肢训练指南不包括步行生物行为干预因此，本II期临床试验的目的是：1）测试步行的益处生物行为干预可改善习惯性日常步行活动; 2）确定潜力在康复中实施步行生物行为干预，评估干预措施的覆盖范围、有效性、采用、实施和维持情况。本试验提出了一种替代战略，以改善生活质量和减少残疾的服务不足，医疗复杂的慢性病人群。该试验直接与NIH资助机会保持一致公告PA-18-146，寻求自我管理干预的临床研究，需要帮助的人的生活质量，以优化功能，预防/延迟残疾，环境