Exercise and Arterial Stiffness in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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.

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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Behavioral: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>12-weeks aerobic exercise intervention | Behavioral: Aerobic exercise<br>* 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.<br>|
| No Intervention: Control<br>Usual care, with recommendations for a healthy lifestyle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness | Pulse wave velocity assessed with Mobil-OGraph ® 24h pulse wave analysis monitor (IEM GmbH, Stolberg, Germany) | Change from baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of inflammation | Interleukin 6 (IL-6), Tumor Necrosis Factor alpha (TNF-α), high sensitivity C-Reactive Protein (hs-CRP), and light chains | Change from baseline to week 12 | 
| Endothelial dysfunction | Intercellular Adhesion Molecule 1 (ICAM-1) | Change from baseline to week 12 | 
| Oxidative stress | Myeloperoxidase (MPO) | Change from baseline to week 12 | 
| Glucose | Blood glucose levels | Change from baseline to week 12 | 
| Insulin | Blood insulin levels | Change from baseline to week 12 | 
| Homeostasis Model Assessment of Insulin Resistance | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Change from baseline to week 12 | 
| Glycated hemoglobin | Glycated hemoglobin (HbA1c %) obtained from blood sample | Change from baseline to week 12 | 
| Lipid Profile | Triglycerides, total cholesterol total, LDL cholesterol and HDL cholesterol | Change from baseline to week 12 | 
| Cardiorespiratory fitness | Assessed by the modified Bruce Test on a treadmill | Change from baseline to week 12 | 
| Muscle strength | Assessed by isometric handgrip dynamometry (hand grip strength test [TKK 5401, Takei Scientific Instruments, Tokyo, Japan] | Change from baseline to week 12 | 
| Flexibility | Assessed by the back scratch test (from the Senior Fitness Test battery) | Change from baseline to week 12 | 
| Waist and hip circumference | Waist and hip circumferences (cm), and calculate waist-to-height ratio (waist in cm divided hip in cm) | Change from baseline to week 12 | 
| Body mass index | Body mass index (BMI, the weight in kilograms divided by the square of the height in meters) | Change from baseline to week 12 | 
| Body composition | Percent body fat, percent fat free mass, and percent muscle mass (assessed by InBody 270 [Biospace Co., USA]) | Change from baseline to week 12 | 
| Resting Heart Rate Variability | Measured with a V800 Polar heart rate monitor | Change from baseline to week 12 | 
| Physical activity | Self-reported physical activity assessed by the International Physical Activity Questionnaire (IPAQ) | Change from baseline to week 12 | 
| Markers of blood coagulation | Fibrinogen and homocystein | Change from baseline to week 12 | 
| Blood markers of renal function | Urea, creatinine, and Glomerular Filtration Rate (in blood sample) | Change from baseline to week 12 | 
| Microalbuminuria | Measured in flesh urine sample | Change from baseline to week 12 | 
| Proteinuria | Measured in flesh urine sample | Change from baseline to week 12 | 
| Blood count | Red blood cells, hemoglobin, medium corpuscular volume, leukocytes, and platelets | Change from baseline to week 12 | 
| Health-related quality of life | Assessed by the 36-item Short Form Health Survey (SF-36) | Change from baseline to week 12 | 
| Depression | Assessed by the Beck Depression Inventory second edition (BDI-II) | Change from baseline to week 12 | 
| Fatigue | Assessed by the Multidimensional Fatigue Inventory (MFI-20) | Change from baseline to week 12 | 
| Sleep quality | Assessed by the Pittsburgh Sleep Quality Index (PSQI) | Change from baseline to week 12 | 
| Sedentary behavior | Assessed by the Sedentary Behavior Questionnaire (SBQ) | Change from baseline to week 12 | 
| Adherence to the Mediterranean Diet | Assessed by food frequency questionnaire | Change from baseline to week 12 | 
| Perceived stress | Assessed by the Perceived Stress Scale (PES) | Change from baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arterial stiffness, Markers of Inflammation, Exercise, Physical fitness, Cardiovascular risk, Autoimmune diseases