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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Emilia Inoue Sato, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01712529
First received: October 20, 2012
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Systemic Lupus Erythematosus
 Behavioral: Supervised physical exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Endothelial function and endothelial progenitor cells (EPCs) number [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Short Form-36

  • Vascular endothelial growth factor (VEGF) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    ELISA

  • Disease activity [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

  • perceived exertion [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Borg scale

  • Fatigue [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Severity fatigue scale

  • Ergospirometric variables [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Cardiopulmonary exercise test


Enrollment: 38
Study Start Date: September 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supervised physical exercise
Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
 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.
No Intervention: No supervised physical exercise
No intervention for 16 weeks

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712529

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil, 04021051
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Emilia I Sato, MD, PhD Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Emilia Inoue Sato, Professor, PHD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01712529     History of Changes
Other Study ID Numbers: 09295-5
Study First Received: October 20, 2012
Last Updated: October 22, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Systemic lupus erythematosus
endothelium
exercise

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013