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Clinical Trials/NCT01712529
NCT01712529
Unknown
N/A

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

Federal University of São Paulo1 site in 1 country38 target enrollmentSeptember 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Systemic Lupus Erythematosus
Sponsor
Federal University of São Paulo
Enrollment
38
Locations
1
Primary Endpoint
Endothelial function and endothelial progenitor cells (EPCs) number
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
November 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Emilia Inoue Sato

Professor, PHD

Federal University of São Paulo

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

Outcomes

Primary Outcomes

Endothelial function and endothelial progenitor cells (EPCs) number

Time Frame: 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 Outcomes

  • Quality of life(16 weeks)
  • Vascular endothelial growth factor (VEGF)(16 weeks)
  • Disease activity(16 weeks)
  • perceived exertion(16 weeks)
  • Fatigue(16 weeks)
  • Ergospirometric variables(16 weeks)

Study Sites (1)

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