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

持续的过度疲劳是SLE最具衰弱性的症状之一，并与功能限制有关，如心肺功能差和体力活动不耐受。SLE疲劳和由此产生的身体虚弱的管理已成为贯穿患者生命周期的临床和社会挑战。有氧运动训练可以改善SLE女性患者的心肺功能，随着这种改善，他们的易疲劳性降低，特别是如果这种易疲劳性是由心肺功能受损介导的。 目前的项目旨在研究在没有明显的心脏、肺或其他全身并发症的SLE妇女中进行剧烈AET的可行性。我们建议在本试验性研究中招募30名久坐不动的成年女性，SLE疾病活动可忽略不计至轻度（SELENA-SLEDAI 4），目标是累积20名可评价受试者。受试者还必须具有疲劳严重程度量表（FSS）综合评分3。我们将仅招募SLE女性患者，因为这是一项小型试点研究，并希望消除体力活动可能存在的性别偏倚混杂因素（约90%的SLE患者为女性）。将从NIH/NIAMS IRP狼疮诊所招募受试者。所有测试和运动训练将在NIH临床中心进行。将有一个单一的治疗条件，包括12周的监督跑步机行走，每周三次，每次30分钟，强度为受试者心率储备的70-80%。 我们试验的主要结局指标是达到无氧阈值所需的时间，这是疲劳的表现标志，不受患者动机或感知的影响。 次要结局变量将包括心肺运动试验（CPET）期间测量的心肺功能的其他指标，伴随肺气体交换、中心循环功能（包括心脏功能和外周血流量的可选指标）和肌肉氧合分析。还将完成一些问卷调查，包括：疲劳严重程度量表、患者报告结局测量信息系统（PROMIS）。 所有这些数据将在有氧运动训练前后获得。 本年度研究产生的出版物： 摘要： Chapman M，Gupta S，Chu J，Naqi M，Manna Z，Mazhar MA，Munday A，Stockman M，Drinkard B，Chin L，Kaplan M，凯瑟R，Chan L，Hasni S.有氧运动在调节女性系统性红斑狼疮患者疲劳中的作用ACR/阿普摘要1595。关节炎Rheumiol 2019; 71（S10）：2840-2842。 Ahmad A，Chin LMK，Chapman M，Manna Z，Chan L，Hasni S，凯瑟RE.有氧运动训练、疲劳和系统性狼疮妇女的易患性ACSM摘要3988。医学科学运动Exer 2020; 52（S5）：S865。

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 measures 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. Publications generated by this year's research: Abstracts: Chapman M, Gupta S, Chu J, Naqi M, Manna Z, Mazhar MA, Munday A, Stockman M, Drinkard B, Chin L, Kaplan M, Keyser R, Chan L, Hasni S. Role of Aerobic Exercise in Modulating Fatigue in Women with Systemic Lupus Erythematosus ACR/ARP abstract 1595. Arthritis Rheumatol 2019; 71(S10):2840-2842. Ahmad A, Chin LMK, Chapman M, Manna Z, Chan L, Hasni S, Keyser RE. Aerobic Exercise Training, Fatigue and Fatigability in Women with Systemic Lupus ACSM Abstract 3988. Med Sci Sports Exer 2020; 52 (S5):S865.