Physical Activity in Pulmonary Arterial Hypertension (ACTiPH)

肺动脉高压的体力活动 (ACTiPH)

• 批准号: 10472728
• 负责人: Steven M Kawut
• 金额: $ 110.65万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-20 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10472728
• 关键词: Accelerometer; Address; Adult; Age; Ancillary Study; Biosensor; Blood Vessels; Cardiac; Cardiopulmonary; Caring; Cessation of life; Childhood; Clinical; Clinical Trials; Clinical assessments; Data; Defect; Disease; Educational Status; Emergency department visit; Endothelium; Enrollment; Environmental Risk Factor; Epoprostenol; Exercise; Frequencies; Hospitalization; Hour; Individual; Intravenous; Lead; Life; Lung; Lung Transplantation; Measures; Medical; Monitor; Muscle; Observational Study; Outcome Study; Outpatients; Patient Monitoring; Patients; Pattern; Peripheral; Personal Satisfaction; Persons; Phenotype; Physical activity; Pilot Projects; Population; Principal Component Analysis; Publishing; Pulmonary Hypertension; Pump; Quality of life; Randomized Clinical Trials; Registries; SF-12; Severities; Smooth Muscle Myocytes; Symptoms; Systemic disease; Testing; Time; United States; Walking; adverse event risk; clinical care; cohort; data streams; design; emotional factor; evidence base; exercise capacity; exercise intervention; fitness; follow-up; health related quality of life; high risk; improved; indexing; innovation; insight; instrument; novel; novel therapeutics; patient oriented; patient registry; physical model; prospective; psychosocial; pulmonary arterial hypertension; residence; right ventricular failure; sedentary; sex; side effect; socioeconomics; supplemental oxygen; treatment effect; vascular bed; wearable sensor technology

Pulmonary arterial hypertension (PAH) is characterized by limitation of physical activity even with current effect treatments. Most observational studies, clinical trials, and outpatient clinical assessments of patients with PAH focus on exercise capacity (the maximal effort a person can achieve under controlled circumstances), measured by cardiopulmonary exercise or six minute walk testing. However, these artificial tests do not capture the intensity, frequency, duration, context, and pattern of physical activity throughout the day or week in the patient’s life. Such an activity “signature” or phenotype may more accurately reflect an individual’s function and perceived health-related quality of life (HRQOL) by providing insight into multisystem function, side effects, and treatment benefits and burdens. A physical activity intervention which is personalized for a PAH patient could lead to improvements in psychosocial function, symptoms, HRQOL, fitness, and even survival. Unfortunately, there have been very few published studies of physical activity in PAH patients, none of which have assessed multidimensionality in a large multicenter cohort. We have performed preliminary studies using traditional accelerometry which have shown that patients with PAH cluster into low, medium, and high activity phenotypes which show differences in six minute walk distance and HRQOL. Functional principal components analysis has identified “signatures” of physical activity patterns throughout the day in PAH. Novel biosensors which continuously capture multiple streams of data in real time (including accelerometry) would provide an innovative approach to remote clinical monitoring and may increase the efficiency and pertinence of clinical trials in PAH. The Pulmonary Hypertension Association Registry (PHAR) has been prospectively collecting data from adult and pediatric PAH patients from centers throughout the United States since 2015. The PHAR has enrolled 1400 patients with 2000 patient-years of follow-up at 52 centers, representing one of the largest multicenter registries of patients with PAH. We propose to measure accelerometry for one week periods biannually for > 1400 patients over four years (~7000 assessments) in the PHAR with high efficiency and low patient burden. We aim to determine the predictors of physical activity phenotype and whether physical activity patterns are associated with health-related quality of life, emergency department visits, hospitalizations, and time to lung transplantation or death in PAH. We will estimate the “minimally important difference” in physical activity which could be used as an end point in clinical trials in PAH. We will incorporate a novel wearable biosensor which could be used to advance these models of physical activity in PAH.

肺动脉高压（PAH）的特征是限制身体活动 效果治疗。大多数观察性研究，临床试验和患者的门诊临床评估 PAH专注于锻炼能力（一个人在受控情况下可以实现的最大努力）， 通过心肺运动或六分钟的步行测试来衡量。但是，这些人工测试没有 捕获全天或一周的体育活动的强度，频率，持续时间，上下文和模式 在病人的生活中。这样的活动“签名”或表型可以更准确地反映出个人的 功能和感知到与健康相关的生活质量（HRQOL），通过提供对多系统功能的见解， 副作用以及治疗益处和伯恩斯。一个个性化的体育锻炼干预措施 PAH患者可能会改善社会心理功能，症状，HRQOL，健身，甚至 生存。不幸的是，对PAH患者的体育活动的发表研究很少，没有 在大型多中心队列中评估了多维性。我们已经进行了初步研究 使用传统的加速度测定法，表明患有PAH簇的患者为低，中和高 活动表型在步行六分钟的距离和HRQOL中显示出差异。功能本金 组件分析已确定了全天在PAH中的体育活动模式的“签名”。小说 实时连续捕获多个数据流的生物传感器（包括加速度计）将 提供一种创新的方法来远程临床监测，并可能提高 PAH的临床试验。 肺高血压协会注册表（PHAR）一直在未来收集数据 自2015年以来，来自美国中心的成人和小儿PAH患者。 在52个中心招募了1400例患者年随访的患者，代表最大的患者之一 PAH患者的多中心注册表。我们建议测量一周的加速度计 在PHAR中，一年一年中的1400名患者（〜7000次评估），高效率和低效率 病人伯恩。我们旨在确定体育锻炼表型的预测因素以及是否体育锻炼 模式与与健康相关的生活质量，急诊科，住院以及 PAH肺移植或死亡的时间。我们将估计物理上的“最小重要差异” 可以用作PAH临床试验的终点的活动。我们将融入一个新颖的可穿戴 可用于推进PAH中这些体育活动模型的生物传感器。