Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Behavioral: Supervised physical exercise
- Registration Number
- NCT01712529
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 38
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supervised physical exercise Supervised physical exercise Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
- Primary Outcome Measures
Name Time Method Endothelial function and endothelial progenitor cells (EPCs) number 16 weeks 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)
- Secondary Outcome Measures
Name Time Method Quality of life 16 weeks Short Form-36
Vascular endothelial growth factor (VEGF) 16 weeks ELISA
Disease activity 16 weeks Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
perceived exertion 16 weeks Borg scale
Fatigue 16 weeks Severity fatigue scale
Ergospirometric variables 16 weeks Cardiopulmonary exercise test
Trial Locations
- Locations (1)
Federal University of Sao Paulo
🇧🇷Sao Paulo, Brazil