Overview

This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatment supervised physical exercise
Sponsor Federal University of São Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date September 2010
End date November 2012
Trial size 38 participants
Trial identifier NCT01712529, 09295-5

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
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 intervention for 16 weeks

Primary Outcomes

Measure
Endothelial function and endothelial progenitor cells (EPCs) number
time frame: 16 weeks

Secondary Outcomes

Measure
Quality of life
time frame: 16 weeks
Vascular endothelial growth factor (VEGF)
time frame: 16 weeks
Disease activity
time frame: 16 weeks
perceived exertion
time frame: 16 weeks
Fatigue
time frame: 16 weeks
Ergospirometric variables
time frame: 16 weeks

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Principal investigator Emilia I Sato, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.