Oxygen-Guided Therapy for Optimal Rehabilitation for Peripheral Artery Disease

氧气引导治疗可实现外周动脉疾病的最佳康复

• 批准号: 10324798
• 负责人: Kevin K. McCully
• 金额: $ 24.73万
• 依托单位: INFRARED RX, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324798
• 关键词: Adherence; Adult; Affect; Age-Years; Aging; Algorithmic Software; American; American Heart Association; Automation; Calibration; Caregivers; Characteristics; Clinical Trials; Complement; Computer software; Data; Data Collection; Devices; Elderly; Exercise; Exercise Therapy; Facilities and Administrative Costs; Feedback; Fostering; Foundations; Funding; Future; Geography; Goals; Home; Human; Hypoxia; Individual; Ischemia; Limb structure; Lower Extremity; Measurement; Measures; Medical Device; Methods; Monitor; Morbidity - disease rate; Muscle; Myalgia; Near-Infrared Spectroscopy; Optics; Outcome; Oxygen; Pain; Pain in lower limb; Pain-Free; Patients; Performance; Peripheral arterial disease; Persons; Pharmacology; Phase; Population; Procedures; Progressive Disease; Property; Protocols documentation; Randomized Clinical Trials; Reference Standards; Rehabilitation therapy; Reporting; Research; Rest; Role; Self-Direction; Signal Transduction; Skeletal Muscle; Stimulus; Supervision; Symptoms; Techniques; Technology; Testing; Time; Tissues; Training; Ulcer; United States; Visual; Walking; Writing; base; claudication; cohort; cost effective; design; exercise intensity; exercise prescription; exercise program; exercise rehabilitation; fitness; haptics; improved; innovative technologies; limb loss; minimally invasive; mortality; new technology; novel strategies; optimal treatments; pain perception; pain reduction; pain symptom; pandemic disease; programs; software development; technology development; treadmill; walking program; walking speed

SUMMARY / ABSTRACT: Atherosclerotic peripheral arterial disease (PAD) of the lower extremity affects over 8.5 million Americans, including 25% of individuals over 80 years of age, and is typified by debilitating leg pain when walking. Untreated, progressive disease results in unrelenting rest pain, ulcers and limb loss.1 Treatment options are limited as revascularization procedures are both expensive and associated with considerable morbidity and mortality whereas pharmacologic therapy is only marginally effective. Supervised exercise therapy, however, is a cost-effective, minimally invasive technique that has proven to be as effective as revascularization for alleviating most common PAD symptoms. Supervised exercise therapy sessions for claudication remain difficult for older adults because of pain during treatment, indirect costs, geographic constraints, pandemic concerns, and concomitant caregiver roles. Infrared Rx, Inc proposes to design and develop novel technology to complement or replace supervised exercise rehabilitation for older adults with PAD. This technology uses near infrared spectroscopy (NIRS) to measure limb hypoxia in real time and thus provide high fidelity, actionable information that allows patients to tailor their own exercise session based on visual or haptic user interfaces – fostering increased adherence to both supervised and self-directed training sessions. As the onset of hypoxia precedes claudication pain, NIRS affords a potential surrogate for tissue ischemia during walking that can be used to direct exercise intensity. We have demonstrated in a small, randomized clinical trial funded by the American Heart Association that a NIRS guided exercise program can effectively improve 6-minute walk times in patients with PAD, but without the debilitating pain of a traditional supervised exercise program.6 This non-invasive, innovative technology has the potential to solve specific challenges that limit the efficacy of supervised exercise therapy for aging adults with PAD; its current form, however, still requires an onsite technician for monitoring during training. Our central hypothesis is that NIRS-guided exercise programs can improve compliance with exercise prescriptions, decrease morbidity, and improve independence in older Americans with PAD. The following proposal will establish the foundation upon which we can develop a commercially viable software analysis platform that allows older adults to engage in exercise with 1) minimal pain and 2) on a self- directed basis. Successful development of this technology requires: 1) identification of the technical parameters needed to reliably make accurate NIRS measurements in older Americans with PAD; 2) automation of data-collection and analysis.

摘要 /摘要： 下肢的动脉粥样硬化外周动脉疾病（PAD）影响超过8.5 百万美国人，包括80岁以上的个人的25％，以 行走时使腿部疼痛使人衰弱。未经治疗的进行性疾病导致无情 休息疼痛，溃疡和肢体损失。1治疗选择受到血运重建的限制 程序既昂贵又与考虑发病率和死亡率有关 而药理学疗法仅略有效率。监督运动 但是，治疗是一种经济高效的，微创的技术，已被证明是 与血运重建同样有效，可以减轻大多数常见的垫子符号。监督 由于疼痛，老年人的锻炼治疗课程仍然很难 在治疗期间，间接成本，地理限制，大流行问题和 伴随的护理人员角色。红外RX，INC提议设计和开发新颖的 补充或替换老年人有监督的运动康复的技术 用垫子。该技术使用近红外光谱（NIR）来测量肢体 实时缺氧，因此提供高保真，可操作的信息，允许 患者根据视觉或触觉用户界面量身定制自己的运动会议 - 促进对监督和自我指导的培训课程的依从性增加。 由于缺氧的发作先于claurauration疼痛，NIR提供了潜在的替代品 对于步行过程中的组织缺血，可用于指导运动强度。我们有 在由美国心脏资助的小型，随机的临床试验中证明 NIRS指导锻炼计划可以有效地改善6分钟步行路程的关联 在患有PAD的患者中，但没有传统监督的疼痛 练习计划。6这种无创的创新技术有可能解决 限制成人老年人运动疗法效率的具体挑战 用垫子;但是，它的当前形式仍然需要一名现场技术人员进行监视 在训练期间。 我们的中心假设是NIRS指导的锻炼计划可以改善 遵守锻炼处方，减少发病率并改善 在美国老年人的独立性。以下建议将确定 我们可以开发商业上可行的软件分析平台的基础 这允许老年人进行运动1）最小的疼痛和2）自我 定向基础。该技术的成功开发需要：1）识别 可靠地进行准确的NIRS测量所需的技术参数 在老年人的垫子中； 2）数据收集和分析的自动化。