Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus|
- Endothelial function and endothelial progenitor cells (EPCs) number [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]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)
- Quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Short Form-36
- Vascular endothelial growth factor (VEGF) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]ELISA
- Disease activity [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
- perceived exertion [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Borg scale
- Fatigue [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Severity fatigue scale
- Ergospirometric variables [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Cardiopulmonary exercise test
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Supervised physical exercise
Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
Behavioral: Supervised physical exercise
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.
No Intervention: No supervised physical exercise
No intervention for 16 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712529
|Federal University of Sao Paulo|
|Sao Paulo, Brazil, 04021051|
|Principal Investigator:||Emilia I Sato, MD, PhD||Federal University of Sao Paulo|