Clinical trial NCT01712529: Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
Official title: Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
endothelium
exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-10-23
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Endothelial function and endothelial progenitor cells (EPCs) number
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 16 weeks
measure: Vascular endothelial growth factor (VEGF)
timeFrame: 16 weeks
measure: Disease activity
timeFrame: 16 weeks
measure: perceived exertion
timeFrame: 16 weeks
measure: Fatigue
timeFrame: 16 weeks
measure: Ergospirometric variables
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Emilia I Sato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: dos Reis-Neto ET, da Silva AE, Monteiro CM, de Camargo LM, Sato EI. Supervised physical exercise improves endothelial function in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2013 Dec;52(12):2187-95. doi: 10.1093/rheumatology/ket283. Epub 2013 Aug 22.