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

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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