Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01712529
• Other study ID #: 09295-5
• Status: Unknown status
• Phase: N/A
• First received: October 20, 2012
• Last updated: October 22, 2012
• Start date: September 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Unknown status
• Enrollment: 38
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function and endothelial progenitor cells (EPCs) number	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)	16 weeks
Secondary	Quality of life	Short Form-36	16 weeks
Secondary	Vascular endothelial growth factor (VEGF)	ELISA	16 weeks
Secondary	Disease activity	Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)	16 weeks
Secondary	perceived exertion	Borg scale	16 weeks
Secondary	Fatigue	Severity fatigue scale	16 weeks
Secondary	Ergospirometric variables	Cardiopulmonary exercise test	16 weeks