Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of supervised physical exercise on endothelial function and number of endothelial progenitor cells (EPCs) in patients with systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise on endothelium derived growth factor (VEGF) levels, disease activity, quality of life, fatigue, perceived exertion and cardiopulmonary exercise test variables.

Detailed Description
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Several studies have shown that cardiovascular morbimortality is more frequent and early in SLE patients than in the general population and cardiovascular disease is an important cause of morbidity and mortality in systemic lupus erythematosus patients. Disturbances in endothelial function are implicated in its pathogenesis. Endothelial function also depends on endothelial progenitor cells (EPCs) that enhance angiogenesis, promote vascular repair and have potential as a marker of cardiovascular disease. Systemic lupus erythematosus patients have endothelial dysfunction and fewer EPCs. There are studies showing improvement of endothelial function and EPCs after physical exercise program in individuals with heart failure, diabetes and coronary arterial disease, but there isn't studies evaluating endothelial function and EPCs after.

Official Title
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Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Behavioral: Supervised physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female systemic lupus erythematosus patients 18 to 45 years of age Fulfilled at least four criteria classification for lupus (ACR criteria, 1997) - Signed the consent form approved by the ethics committee of the institution Exclusion Criteria: Hemoglobin < 10 mg/dL Neuropsychiatric, pulmonary, articular or vascular damage that would prevent the practice of exercise Coronary disease or heart failure, functional class ≥ II Pulmonary hypertension Uncontrolled hypertension Creatinine ≥ 1.4 mg/dL Body mass index (BMI) ≥ 35 kg/m2 Diabetes mellitus Uncontrolled hypothyroidism Smoking in the last 12 months Pregnancy Menopause Use of statins in the last three months Practice of physical exercise in past three months Overlap with other autoimmune rheumatic diseases, except antiphospholipid syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised physical exercise<br>Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter. | Behavioral: Supervised physical exercise<br>* Women with systemic lupus erythematosus with availability to perform physical exercise were allocated in exercise group (EG) to practice supervised physical exercise for one hour, three times a week for 16 weeks. Those who were not available for this activity were allocated in the control group (CG). Intervention consisted of walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.<br>|
| No Intervention: No supervised physical exercise<br>No intervention for 16 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function and endothelial progenitor cells (EPCs) number | Patients were evaluated at baseline and after 16 weeks by high-resolution ultrasound of brachial artery in resting conditions, after reactive hyperaemia (flow-mediated dilation-FMD) and after oral glyceryl trinitrate to assess endothelial function; EPCs were evaluated by flow cytometry using anti-CD34 (cluster of differentiation 34) (FITC), anti-CD133 (PE) and anti-kinase domain receptor (KDR) (APC) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Short Form-36 | 16 weeks | 
| Vascular endothelial growth factor (VEGF) | ELISA | 16 weeks | 
| Disease activity | Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) | 16 weeks | 
| perceived exertion | Borg scale | 16 weeks | 
| Fatigue | Severity fatigue scale | 16 weeks | 
| Ergospirometric variables | Cardiopulmonary exercise test | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic lupus erythematosus, endothelium, exercise