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，其中包括 25% 80 岁以上的人，其典型代表是 行走时腿部疼痛若不及时治疗，会导致病情进展，导致病情持续恶化。 静息痛、溃疡和肢体丧失。1 治疗选择因血运重建而受到限制 手术既昂贵又与相当大的发病率和死亡率相关 而药物治疗的效果有限。 然而，治疗是一种经济有效的微创技术，已被证明是有效的 与血运重建术一样有效地缓解最常见的 PAD 症状。 由于疼痛，老年人跛行的运动疗法仍然很困难 在治疗期间，间接成本、地理限制、流行病担忧，以及 Infrared Rx, Inc 提议设计和开发新颖的护理人员角色。 补充或替代老年人监督运动康复的技术 该技术使用近红外光谱 (NIRS) 来测量肢体。 实时缺氧，从而提供高保真、可操作的信息，使 患者根据视觉或触觉用户界面定制自己的锻炼课程 – 促进更多地遵守监督和自我指导的培训课程。 由于缺氧先于跛行疼痛发生，NIRS 提供了一种潜在的替代方法 用于步行过程中的组织缺血，可用于指导运动强度。 美国心脏基金会资助的一项小型随机临床试验证明了这一点 协会认为 NIRS 引导锻炼计划可以有效改善 6 分钟步行 PAD 患者的时间，但没有传统监督下的令人衰弱的疼痛 锻炼计划。6 这种非侵入性创新技术有可能解决 限制老年人监督运动疗法功效的具体挑战 然而，其目前的形式仍然需要现场技术人员进行监控 训练期间。 我们的中心假设是 NIRS 引导的锻炼计划可以改善 遵守运动处方、降低发病率并改善 患有 PAD 的美国老年人的独立性 以下提案将建立 在此基础上我们可以开发商业上可行的软件分析平台 这使得老年人能够在 1) 最小疼痛和 2) 自我锻炼的情况下进行锻炼。 这项技术的成功开发需要：1）鉴定。 可靠地进行准确的 NIRS 测量所需的技术参数 患有 PAD 的美国老年人；2）数据收集和分析的自动化。