Pilot Study Characterizing Aerobic Exercise in Women with Systemic Lupus Erythematosus (Exercise SLE Pilot)

持续性过度疲劳是系统性红斑狼疮最令人衰弱的症状之一，并与心肺功能低下和体力活动不耐受等功能障碍有关。系统性红斑狼疮疲劳和由此导致的身体虚弱的处理已成为患者一生中面临的临床和社会挑战。有氧运动训练可以改善系统性红斑狼疮患者的心肺功能，随着这种改善，她们的疲劳性迅速降低，特别是如果这种疲劳性是由心肺功能受损引起的。 目前的项目旨在研究在没有明显的心脏、肺部或其他全身并发症的系统性红斑狼疮患者中进行积极的AET的可行性。我们建议在这项初步研究中招募30名久坐不动、患有轻微至轻度SLE疾病活动的成年女性(Selena-SLEDAI 4)，目标是收集20名可评估的受试者。受试者还必须有疲劳严重程度量表(FSS)综合评分3。我们将限制招募SLE女性，因为这是一项小型的试点研究，希望消除可能存在性别偏见的体力活动混杂因素(大约90%的SLE患者是女性)。受试者将从NIH/NIAMS IRP狼疮诊所招募。所有测试和运动训练都将在NIH临床中心进行。将有一个单一的治疗条件，包括12周的监督跑步机步行，每周三次，每次30分钟，强度为受试者心率储备的70%-80%。 我们试验的主要结果将是达到无氧阈值所需的时间，这是不受患者动机或感知影响的疲劳性的表现标志。次要结果变量将包括在伴随肺气体交换的心肺运动试验(CPET)中测量的心肺功能的其他指标、中心循环功能(包括心脏功能和一项可选的外周血流量指标)和肌肉氧合分析。还将完成一系列问卷，包括：疲劳严重程度量表、患者报告结果测量信息系统(PROIS)。所有这些数据都将在有氧运动训练前后获得。 这项研究于2021年2月停止招聘，并继续进行数据分析。虽然我们的目标是20个可评估的受试者，但新冠肺炎大流行期间实施的访问限制意味着2020年暂停研究活动。我们评估了CC中央科学审查委员会建议的16个完成的受试者是否取得了初步结果，并找到了足够的权力来结束研究对受试者的登记。 在22财年，我们向临床试验注册中心(ct.gov)报告了这项研究的结果。其他数据分析和手稿准备工作正在进行中，并将陆续进行。 今年研究产生的出版物： 摘要： 1.Morris Z，Chan L，Hasni S，Keyser R，Chin LMK。在ACSM年会上发表的关于系统性红斑狼疮女性有氧运动训练后VO2动力学的改善；将在Med Sci Sports Exer上发表

Persistent, excessive fatigue is one of the most debilitating symptoms of SLE and is associated with functional limitations such as poor cardiorespiratory capacity and physical activity intolerance. Management of SLE-fatigue and the resultant physical debilitation has become a clinical and social challenge throughout the patients lifespan. Aerobic exercise training could improve cardiorespiratory capacity in women with SLE, and with that improvement, precipitate a reduction in their fatigability, particularly if that fatigability is mediated by impaired cardiorespiratory function. The current project aims to examine the feasibility of vigorous AET in women with SLE who do not have overt cardiac, pulmonary or other systemic complications. We propose to enroll 30 sedentary, adult, women with negligible to mild SLE disease activity (SELENA-SLEDAI 4) in this pilot study with the goal of accruing 20 evaluable subjects. Subjects must also have a Fatigue Severity Scale (FSS) composite score 3. We will restrict our recruitment to women with SLE as this is a small pilot study and would like to eliminate possible gender-biased confounders of physical activity (approximately 90% of patients with SLE are women). Subjects will be recruited from the NIH/NIAMS IRP Lupus Clinics. All tests and exercise training will be conducted at the NIH Clinical Center. There will be a single treatment condition consisting of 12-weeks of supervised treadmill walking, three times a week, for 30 minutes per session, at an intensity of 70-80% of the subjects heart rate reserve. The primary outcome measure for our trial will be the time taken to attain the anaerobic threshold, which is a performance marker of fatigability that is unaffected by patient motivation or perception. Secondary outcome variables will include other measures of cardiorespiratory capacity measured during a cardiopulmonary exercise test (CPET) with accompanying pulmonary gas exchange, central circulatory function (including heart function and an optional measure of peripheral blood flow) and muscle oxygenation analyses. A number of questionnaires will also be completed including: Fatigue Severity Scale, Patient Reported Outcomes Measurement Information System (PROMIS). All of these data will be obtained before and after aerobic exercise training. This study was closed in February 2021 to recruitment and continues in data analysis. While we were targeting 20 evaluable subjects, the visit restrictions in place during the COVID-19 pandemic meant suspending research activities in 2020. We evaluated whether the primary outcome was achieved with the 16 completed subjects as recommended by the CC Central Scientific Review Committee, and found sufficient power to close the study to subject enrollment. In FY22, we reported results from this study to the clinicaltrials.gov (CT.gov) registry. Other data analysis and manuscript preparations are in progress and will be forthcoming. Publications generated by this year's research: Abstracts: 1. Morris Z, Chan L, Hasni S, Keyser R, Chin LMK. Improved VO2 on-kinetics after aerobic exercise training in women with Systemic Lupus Erythematosus Presented at ACSM Annual Conference; to be published in Med Sci Sports Exer