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.

总结/摘要： 下肢动脉粥样硬化性外周动脉疾病（PAD）影响超过8.5 百万美国人，包括25%的80岁以上的人， 走路时腿部疼痛。未经治疗的进行性疾病会导致 静息痛、溃疡和肢体丧失。1由于血运重建， 手术既昂贵又与相当高的发病率和死亡率相关 而药物治疗仅仅是边缘有效的。监督锻炼 然而，治疗是一种具有成本效益的微创技术， 与血运重建术一样有效缓解大多数常见PAD症状。监督 由于疼痛，对于老年人来说，跛行的运动治疗仍然很困难 治疗期间，间接费用，地理限制，流行病问题， 伴随的照顾者角色。Infrared Rx，Inc建议设计和开发新的 补充或取代老年人监督运动康复的技术 关于PAD该技术使用近红外光谱（NIRS）测量肢体 因此提供高保真度、可操作信息， 患者基于视觉或触觉用户界面定制他们自己的锻炼会话- 促进更多地参加监督和自我指导的培训课程。 由于缺氧的发作先于跛行疼痛，近红外光谱提供了一个潜在的替代 用于步行过程中的组织缺血，可用于指导运动强度。我们有 在美国心脏基金资助的一项小型随机临床试验中证实， 协会认为，NIRS指导的运动计划可以有效地改善6分钟步行 次，但没有传统监督的衰弱性疼痛 6这种非侵入性的创新技术有可能解决 限制老年人监督运动疗法疗效的具体挑战 与PAD;其目前的形式，但是，仍然需要一个现场技术人员进行监测 在训练中。 我们的中心假设是，NIRS指导的锻炼计划可以改善 遵守运动处方，降低发病率，并改善 美国老年PAD患者的独立性。以下建议将建立 在此基础上，我们可以开发商业上可行的软件分析平台 这使得老年人可以在1）最小的痛苦和2）自我锻炼的情况下进行锻炼， 定向基础。这项技术的成功开发需要：1）识别 可靠地进行精确的NIRS测量所需的技术参数 在美国老年PAD患者中; 2）数据收集和分析的自动化。