Fatigue and Lifestyle Physical Activity in SLE

描述（由申请人提供）：系统性红斑狼疮（SLE）在美国影响多达150万人。尽管自20世纪70年代以来SLE患者的超额死亡率有所下降，但仍存在大量发病率。疲劳是这种慢性不可治愈的炎症性自身免疫性疾病患者最具致残性和持久性的主诉。疲劳的后果是显着的，包括生活质量下降，工作残疾的风险增加，以及相关的医疗保健费用增加。该R21应用程序的首要目标是探索改善两个结构（体力活动和疲劳）测量的方法，作为更广泛努力的必要第一步，使用行为管理干预，通过增加SLE患者的生活方式体力活动来降低疲劳评分。我们提出了一个新的应用相对较新的技术来客观地测量身体活动（三轴加速度计，它提供了一个验证的测量日常身体活动在社区居住环境）。此外，我们建议使用计算机自适应测试（CAT）患者报告结果（PRO）来测量疲劳的协变量，这些结果是使用最先进的认知，定性，定量和健康调查方法开发的，作为NIH资助的患者报告结果测量信息系统（PROMIS）的一部分。PROMIS工具的开发是为了标准化受许多慢性疾病影响的自我报告健康领域的测量，这些工具提供了最大限度地减少患者负担和最大限度地提高精度的优势。 使用横断面研究设计，在R21申请中将测试以下具体目标：目标1。评价通过加速度计测量的身体活动的频率、强度和持续时间，以获得患者特异性平均每日活动计数、平均每日中度至剧烈活动分钟数（MVPA）（定义为e 2020活动计数/min）、平均每日轻度身体活动分钟数（< 2020活动计数/min）和平均每日任何活动分钟数（即， 非零活动计数分钟）。 目标2.描述SLE患者客观测量的体力活动与疲劳（主要结局，疲劳严重程度评分（FSS））之间的横断面关系。我们将在调整和不调整影响疲劳的主要因素（包括睡眠和觉醒障碍、抑郁、焦虑和使用PROMIS工具的疼痛干扰）以及SLE疾病活动和严重程度的情况下进行这项研究。 疲劳的不良临床，社会和经济影响支持迫切需要改善对SLE疲劳因素的理解，这是NIH/NIAMS专著“狼疮研究的未来方向”中确定的研究优先事项。 公共卫生相关性：系统性红斑狼疮（SLE）在美国影响多达150万人。尽管自20世纪70年代以来SLE患者的超额死亡率有所下降，但仍存在大量发病率。疲劳是这种慢性不可治愈的炎症性自身免疫性疾病患者最具致残性和持久性的主诉。疲劳的后果是显着的，包括生活质量下降，工作残疾的风险增加和相关的医疗保健费用增加。该R21应用程序的总体目标是确定两个结构（疲劳和体力活动）之间的关系，作为更广泛努力实施行为管理干预的必要第一步，通过增加SLE患者的生活方式体力活动来对抗疲劳。因此，我们提出了以下具体目标和主要假设，以在此R21应用程序中进行测试：目标1。评价通过加速度计测量的身体活动的频率、强度和持续时间，以获得患者特异性平均每日活动计数、平均每日中度至剧烈活动分钟数（MVPA）（定义为e 2020活动计数/min）、平均每日轻度身体活动分钟数（< 2020活动计数/min）和平均每日任何活动分钟数（即，非零活动计数分钟）。目标2.描述SLE患者客观测量的体力活动与疲劳（主要结局，疲劳严重程度评分，[FSS]）之间的横断面关系。我们将在调整和不调整影响疲劳的主要因素（包括睡眠和觉醒障碍、抑郁、焦虑和使用PROMIS工具的疼痛干扰）以及SLE疾病活动和严重程度的情况下进行这项研究。疲劳的不良临床、社会和经济影响支持了对SLE疲劳因素的进一步了解的迫切需要，这是NIH/NIAMS专著《狼疮研究的未来方向》中确定的研究重点。

DESCRIPTION (provided by applicant): Systemic lupus erythematosus (SLE) affects up to 1.5 million persons in the US. Although excess mortality has decreased in SLE patients since the 1970's, substantial morbidity persists. Fatigue is the most disabling and enduring complaint in patients affected with this chronic incurable inflammatory autoimmune disease. The ramifications of fatigue are significant and include decreased quality of life, an increased risk of work disability, and an associated increase in health care costs. The overarching goal of this R21 application is to explore ways to improve the measurement of two constructs, physical activity and fatigue, as a necessary first step in a broader effort to use a behavior management intervention to lower fatigue scores by increasing lifestyle physical activity in persons with SLE. We propose a novel application of a relatively new technology to objectively measure physical activity (triaxial accelerometry, which provides a validated measurement of daily physical activity in the community dwelling setting). In addition, we propose to measure covariates of fatigue using computerized adaptive tests (CATs) patient-reported outcomes (PROs) that have been developed using state-of-the-art cognitive, qualitative, quantitative and health survey methodologies as part of the NIH-funded Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS tools were developed to standardize measurement of self-reported health domains affected by many chronic illnesses and these tools offer the advantages of minimizing patient burden and maximizing precision. Using a cross-sectional study design, the following specific aims will be tested in this R21 application: Aim 1. Evaluate the frequency, intensity, and duration of physical activity as measured by accelerometry to obtain patient-specific average daily activity counts, average daily moderate-to- vigorous minutes of activity (MVPA) (defined as e 2020 activity counts/min), average daily minutes of light physical activity (< 2020 activity counts/min), and average daily minutes of any activity (i.e., minutes of non-zero activity counts) in patients with SLE. Aim 2. Characterize the cross-sectional relationships between objectively measured physical activity and fatigue (primary outcome, Fatigue Severity Score, (FSS) in patients with SLE. We will do this with and without adjustment for the major factors that influence fatigue including sleep and wake disturbance, depression, anxiety, and pain interference using PROMIS tools, and SLE disease activity and severity. The adverse clinical, social, and economic implications of fatigue support the critical need for an improved understanding of factors contributing to fatigue in SLE, a research priority identified in the NIH/NIAMS monograph entitled, "The Future Directions of Lupus Research". PUBLIC HEALTH RELEVANCE: Systemic lupus erythematosus (SLE) affects up to 1.5 million persons in the US. Although excess mortality has decreased in SLE patients since the 1970's, substantial morbidity persists. Fatigue is the most disabling and enduring complaint in patients affected with this chronic incurable inflammatory autoimmune disease. The ramifications of fatigue are significant and include decreased quality of life, an increased risk of work disability and an associated increase in health care costs. The overall goal of this R21 application is to determine the relationship between two constructs, fatigue and physical activity, as a necessary first step in a broader effort to implement a behavior management intervention that combats fatigue by increasing lifestyle physical activity in persons with SLE. Thus, we propose the following specific aims and primary hypothesis to be tested in this R21 application: Aim 1. Evaluate the frequency, intensity, and duration of physical activity as measured by accelerometry to obtain patient-specific average daily activity counts, average daily moderate-to-vigorous minutes of activity (MVPA) (defined as e 2020 activity counts/min), average daily minutes of light physical activity (< 2020 activity counts/min), and average daily minutes of any activity (i.e., minutes of non-zero activity counts) in patients with SLE. Aim 2. Characterize the cross-sectional relationships between objectively measured physical activity and fatigue (primary outcome, Fatigue Severity Score, [FSS]) in patients with SLE. We will do this with and without adjustment for the major factors that influence fatigue including sleep and wake disturbance, depression, anxiety, and pain interference using PROMIS tools, and SLE disease activity and severity. The adverse clinical, social, and economic implications of fatigue support the critical need for an improved understanding of factors contributing to fatigue in SLE, a research priority identified in the NIH/NIAMS monograph entitled, The Future Directions of Lupus Research.