We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01712529
Recruitment Status : Unknown
Verified October 2012 by Emilia Inoue Sato, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Behavioral: Supervised physical exercise

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2010
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quality of life [ Time Frame: 16 weeks ]
    Short Form-36

  2. Vascular endothelial growth factor (VEGF) [ Time Frame: 16 weeks ]
    ELISA

  3. Disease activity [ Time Frame: 16 weeks ]
    Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

  4. perceived exertion [ Time Frame: 16 weeks ]
    Borg scale

  5. Fatigue [ Time Frame: 16 weeks ]
    Severity fatigue scale

  6. Ergospirometric variables [ Time Frame: 16 weeks ]
    Cardiopulmonary exercise test


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Emilia Inoue Sato, 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