Exercise and Arterial Stiffness in Systemic Lupus Erythematosus (EJERCITALES)

Effects of an Aerobic Exercise Intervention Program on Arterial Stiffness and Inflammation in Women With Systemic Lupus Erythematosus

Patients with Systemic Lupus Erythematosus (SLE) have increased arterial stiffness, which leads to cardiovascular diseases (CVD) of arteriosclerotic origin, which are the main cause of mortality in these patients. Exercise is a modifiable factor that reduces cardiovascular mortality and associated risk factors in the general population. Preliminary studies suggest that exercise may improve endothelial function and lipid profile in patients with SLE. However, whether meeting the international physical activity guidelines from the American College of Sports Medicine (ACSM; i.e. ≥150 min / week of moderate to vigorous intensity physical activity) can improve arterial stiffness (subclinical atherosclerosis marker) and inflammation is unknown. The primary aim of this study is to assess the effect of an exercise program based on meeting the ACSM physical activity guidelines on arterial stiffness and inflammation in patients with SLE. The secondary aim is to assess the effect of an exercise program based on meeting the ACSM physical activity guidelines on endothelial function, oxidative stress, as well as other cardiometabolic risk factors, physical fitness, health-related quality of life, and other psychosocial outcomes. Our hypothesis is that meeting the ACSM guidelines will improve arterial stiffness and inflammation in patients with SLE. The study is a non-randomized clinical trial. To minimize selection bias, participants in the intervention and control groups will be matched by age, BMI, and disease activity (SLEDAI), which are important contributors to arterial stiffness.

Arterial stiffness, Markers of Inflammation, Exercise, Physical fitness, Cardiovascular risk, Autoimmune diseases

12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous [40-85% of the individual's heart rate reserve] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.

Pulse wave velocity assessed with Mobil-OGraph ® 24h pulse wave analysis monitor (IEM GmbH, Stolberg, Germany)

Interleukin 6 (IL-6), Tumor Necrosis Factor alpha (TNF-α), high sensitivity C-Reactive Protein (hs-CRP), and light chains

Assessed by isometric handgrip dynamometry (hand grip strength test [TKK 5401, Takei Scientific Instruments, Tokyo, Japan]

Waist and hip circumferences (cm), and calculate waist-to-height ratio (waist in cm divided hip in cm)

Percent body fat, percent fat free mass, and percent muscle mass (assessed by InBody 270 [Biospace Co., USA])

Inclusion Criteria: Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology criteria (presenting at least 4 classification criteria). Follow-up of at least 12 months at our Unit. Clinical and treatment stability during the 6 months prior to the study. Not performing regular exercise (defined as < 60min/week of structured exercise) Exclusion Criteria: Biological treatment in the previous 6 months or to need prednisone dosis >10 mg/day. Background of clinical cardiovascular disease in the last year. To present contraindications to perform exercise. Other associated rheumatic conditions. Pregnancy. Acute renal failure. Cardiac or pulmonary involvement. Body Mass Index > 35 Not being able to read, understand and sign written informed consent.