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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01712529
Enrollment
38
Registered
2012-10-23
Start date
2010-09-30
Completion date
2012-11-30
Last updated
2012-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus, endothelium, exercise

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.

Interventions

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.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Endothelial function and endothelial progenitor cells (EPCs) number16 weeksPatients 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

MeasureTime frameDescription
Vascular endothelial growth factor (VEGF)16 weeksELISA
Disease activity16 weeksSystemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Quality of life16 weeksShort Form-36
Fatigue16 weeksSeverity fatigue scale
Ergospirometric variables16 weeksCardiopulmonary exercise test
perceived exertion16 weeksBorg scale

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026